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Implants & Prosthetics

🏥 Medical Devices • 4,540 recalls

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Abbott Vascular

Class I - Dangerous

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Nov 6, 2024 Implants & Prosthetics Nationwide View Details →

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

Abbott Medical

Class I - Dangerous

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

Nov 21, 2024 Implants & Prosthetics Nationwide View Details →

MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

Moximed

Class I - Dangerous

Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.

Dec 2, 2024 Implants & Prosthetics Nationwide View Details →

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Dec 5, 2024 Implants & Prosthetics Nationwide View Details →

MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK, REF CDS840459R; 8) CAROTID-LF, REF CDS860039K; 9) CAROTID-LF, REF CDS860039L; 10) OPEN HEART ADULT KIT, REF CDS981319AD; 11) BAPTIST AAA, REF CDS982400M; 12) ZALE PUMP CDS, REF CDS983187G; 13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G; 14) MAJOR VASCULAR, REF CDS983489K; 15) CAROTID, REF CDS983495N; 16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 17) AV FISTULA, REF CDS983638K; 18) PERIPHERAL VASCULAR CDS, REF CDS983723I; 19) ACH OPEN HEART, REF CDS983773J; 20) VASCULAR, REF CDS984255K; 21) VASCULAR CDS, REF CDS984275I; 22) OPEN HEART CDS, REF CDS984276O; 23) OPEN HEART CDS, REF CDS984355G; 24) OPEN HEART CDS, REF CDS984355I; 25) SMH VASCULAR CDS, REF CDS984584M; 26) VASCULAR CDS-LF, REF CDS984594G; 27) VASCULAR CDS-LF, REF CDS984594I; 28) VASCULAR, REF CDS985355F; 29) SJ BYPASS LEG CUSTOM PACK-LF, REF DYNJ0042944J; 30) SJ BYPS LEG CSTM PK RFID-LF, REF DYNJ0042944K; 31) AV FISTULA PACK-LF, REF DYNJ0131782G; 32) AV FISTULA PACK-LF, REF DYNJ0131782I; 33) AV FISTULA PACK-LF, REF DYNJ0131782J; 34) AV FISTULA PACK-LF, REF DYNJ0131782K; 35) VASCULAR PACK, REF DYNJ02467M; 36) OPEN HEART PACK A & B, REF DYNJ0283397U; 37) VASCULAR PACK-LF, REF DYNJ0421380P; 38) MAJOR VASCULAR PACK-LF, REF DYNJ0488546J; 39) SJ CARDIAC A PACK RFID-LF, REF DYNJ0619768M; 40) SJ PACEMAKER PACK RFID-LF, REF DYNJ0619848O; 41) PACEMAKER PACK-LF, REF DYNJ0826630N; 42) AV SHUNT PACK-LF, REF DYNJ0842516G; 43) GENERAL ENDO PACK-LF, REF DYNJ0842873K; 44) PACEMAKER PACK-LF, REF DYNJ0843217M; 45) PACEMAKER PACK-LF, REF DYNJ0843217N; 46) PACEMAKER PACK-LF, REF DYNJ0867353I; 47) PACEMAKER PACK-LF, REF DYNJ0867353J; 48) CAROTID ARTERY PACK-LF, REF DYNJ0882509L; 49) CAROTID ARTERY PACK-LF, REF DYNJ0882509N; 50) VASCULAR PACK-LF, REF DYNJ0901358J; 51) VASCULAR PACK-LF, REF DYNJ0901358K; 52) HEALTH ALL VASCULAR PACK-LF, REF DYNJ19538F; 53) OPEN HEART A&B PK-LF, REF DYNJ20888K; 54) OPEN HEART A&B PK-LF, REF DYNJ20888L; 55) GEN FEM POP #14-RF, REF DYNJ21877W; 56) CABG PACK A&B, REF DYNJ21971AD; 57) VASCULAR PACK, REF DYNJ22350L; 58) SVMMC CORE OPEN HEART PACK-LF, REF DYNJ22971T; 59) OPEN HEART SUPPLEMENT A, REF DYNJ24591AB; 60) SVMMC OPEN HEART ADD ON PACK, REF DYNJ24634O; 61) SVMMC PERMANENT PACING PACK, REF DYNJ24746I; 62) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 63) PACEMAKER PACK, REF DYNJ30928O; 64) VASCULAR PACK, REF DYNJ31902N; 65) DB CAROTID PACK-LF, REF DYNJ33579F; 66) DB ENDOVASCULAR AAA PACK-LF, REF DYNJ33689I; 67) PACEMAKER ICD PK, REF DYNJ34795K; 68) OPEN HEART PACK A&B, REF DYNJ35854D; 69) PACEMAKER PACK, REF DYNJ36025D; 70) RRMC PACEMAKER PACK, REF DYNJ36337G; 71) OPEN HEART PACK, REF DYNJ37284J; 72) PACEMAKER PACK, REF DYNJ37557D; 73) PEDIATRIC CARDIAC MINOR, REF DYNJ37618D; 74) ACH CABG ADD-ON, REF DYNJ38175L; 75) PACEMAKER SET UP PACK, REF DYNJ38232B; 76) PACEMAKER PACK-LF, REF DYNJ38643F; 77) PACEMAKER PACK-LF, REF DYNJ38702A; 78) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439K; 79) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439L; 80) CARDIOVASCULAR PACK, REF DYNJ42921G; 81) CABG PACK-LF, REF DYNJ43207K; 82) HEART DRAPING PACK-LF, REF DYNJ43214F; 83) VASCULAR PACK, REF DYNJ43276I; 84) SVMMC VASCULAR MAJOR PACK, REF DYNJ43777J; 85) OPEN HEART PACK A AND B, REF DYNJ43858B; 86) SVMMC CAROTID PACK, REF DYNJ43861F; 87) MAJOR VASCULAR PACK, REF DYNJ44161G; 88) MINOR VASCULAR PACK, REF DYNJ44164F; 89) VASCULAR ACCESS PACK, REF DYNJ44172D; 90) AV FISTULA PACK, REF DYNJ44704J; 91) AAA PACK, REF DYNJ44847I; 92) CARDIAC VASCULAR PACK, REF DYNJ44854M; 93) CASTRO CABG-COMPONENT PACK, REF DYNJ44857S; 94) CASTRO CABG-COMPONENT PACK, REF DYNJ44857T; 95) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 96) FIST

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Implants & Prosthetics Nationwide View Details →

MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, REF DYNJ0867331G; 6) TOTAL KNEE BASIN B PACK-LF, REF DYNJ0867555L; 7) ST. ANNE'S MINOR BASIN PACK, REF DYNJ24622K; 8) ST. ANNE'S MAJOR BASIN SET UP, REF DYNJ24628M; 9) MAJOR BASIN SET, REF DYNJ41285B; 10) BASIN PACK, REF DYNJ50123D; 11) MAJOR BASIN TRAY, REF DYNJ54461F; 12) MAJOR BASIN TRAY, REF DYNJ54461G; 13) MAJOR BASIN TRAY, REF DYNJ54461I; 14) TR-MINOR KIT-LF, REF DYNJ54801F; 15) TR-MAJOR KIT-LF, REF DYNJ54802I; 16) MAJOR BASIN PACK, REF DYNJ59816A; 17) SINGLE BASIN PACK ST VINCENT, REF DYNJ60529D; 18) BASIN PACK, REF DYNJ60812B; 19) BASIN PACK SH, REF DYNJ60812C; 20) PLASTIC BASIN PACK, REF DYNJ63883C; 21) MINOR PACK, REF DYNJ63961D; 22) OSC BREAST PACK, REF DYNJ65808B; 23) OSC BASIN PACK, REF DYNJ68217A; 24) DELNOR VASCULAR BASIN PACK, REF DYNJ82257; 25) DELNOR BASIN PACK, REF DYNJ82267; 26) STAZ MAJOR BASIN, REF DYNJ909785; 27) LUMBAR, REF DYNJ909923

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Implants & Prosthetics Nationwide View Details →

MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Implants & Prosthetics Nationwide View Details →

MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Implants & Prosthetics Nationwide View Details →

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.

MicroSurgical Technology

Class I - Dangerous

Due to pin coming off of handles.

Sep 17, 2024 Implants & Prosthetics View Details →

Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.

Abbott Medical

Class I - Dangerous

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Oct 1, 2024 Implants & Prosthetics Nationwide View Details →

Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN

Abbott Medical

Class I - Dangerous

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Oct 1, 2024 Implants & Prosthetics Nationwide View Details →

NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.

Novosource

Class I - Dangerous

Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

Sep 19, 2024 Implants & Prosthetics View Details →
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