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Implants & Prosthetics

ðŸĨ Medical Devices â€Ē 4,540 recalls

Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 00401000042 00401000043 00401000044 00401000045 00401000046 00401000047 00401000048 00401000049 00401000050 00401000051 00401000052 00401000053 00401000054 00401000055 00402100857 00402100863 00402101243 00402101244 00402200040 00402200042 00402200051 00402200057 00408801106 00408801206 00408801226 00408801236 00408801306 00408801326 00408801336 00408801356 00408801376 00408801406 00408801426 00408801436 00408801456 00408801476 00408801506 00408801526 00408801536 00408801556 00408801576 00408801606 00408801626 00408801636 00408801656 00408801706 00408801806 00455500700 00455501001 00455502000 00455502001 00455503000 00455503001 00455504001 00500103800 00500103900 00500104000 00500104100 00500104200 00500104300 00500104400 00500104500 00500104600 00500104700 00500104800 00500104900 00500105000 00500105100 00500105200 00500105300 00500105400 00500105500 00500105700 00500105800 00500106000 00500106200 00500106400 00500106600 00500106800 00500107000 00620003620 00620003820 00620004020 00620004021 00620004023 00620004220 00620004221 00620004223 00620004420 00620004421 00620004423 00620004424 00620004620 00620004621 00620004623 00620004820 00620004821 00620004822 00620004823 00620005020 00620005021 00620005022 00620005023 00620005220 00620005221 00620005222 00620005223 00620005420 00620005421 00620005422 00620005423 00620005424 00620005620 00620005621 00620005622 00620005623 00620005624 00620005820 00620005821 00620005822 00620005823 00620005824 00620006020 00620006021 00620006022 00620006023 00620006220 00620006221 00620006222 00620006223 00620006224 00620006420 00620006421 00620006422 00620006423 00620006620 00620006621 00620006622 00620006623 00620006624 00620006820 00620006821 00620006822 00620006823 00620006824 00620007020 00620007021 00620007022 00620007023 00620007220 00620007620 00620008020 00620104800 00620105000 00620105200 00620105400 00620105600 00620105800 00620106000 00620106200 00620106400 00620106600 00620107000 00620203820 00620203822 00620204020 00620204022 00620204220 00620204222 00620204420 00620204422 00620204620 00620204622 00620204820 00620204821 00620204822 00620205020 00620205021 00620205022 00620205220 00620205221 00620205222 00620205420 00620205421 00620205422 00620205620 00620205621 00620205622 00620205820 00620205821 00620205822 00620206020 00620206022 00620206220 00620206222 00620206420 00620206422 00620206620 00620206622 00620206820 00620206822 00620207020 00620207022 00620207220 00620207420 00620207620 00620208020 00633410132 00640004822 00640005020 00640005022 00640005222 00640005420 00640005422 00640005620 00640005622 00640005822 00640006022 00640006220 00640006222 00640006420 00640006422 00640006620 00640006622 00640006820 00640006822 00640007020 00640007022 00671000301 00671000302 00671000401 00671000402 00671000501 00671000502 00671000601 00671000602 00671000701 00671000702 00671000801 00671000802 00671000901 00671000902 00672000102 00672000111 00672000112 00672000201 00672000202 00672000211 00672000212 00672000311 00672000411 00672000412 00672000501 00672000502 00672000512 00672000601 00672000602 00672000611 00672000612 00763301100 00763301200 00763301300 00763301400 00763401000 00763401100 00763401200 00763401300 00763401400 00763401500 00763401600 00765301101 00765301140 00765301201 00765301240 00765301301 00765301340 00765301401 00765301440 00765301501 00765301540 00765301601 00765401100 00765401400 00771100410 00771100440 00771100500 00771100510

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Implants & Prosthetics Nationwide View Details →

Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958

Implant Direct Sybron Manufacturing

Class I - Dangerous

The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.

Sep 6, 2018 Implants & Prosthetics View Details →

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

OrthoPediatrics

Class I - Dangerous

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Aug 19, 2019 Implants & Prosthetics Nationwide View Details →

Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

OrthoPediatrics

Class I - Dangerous

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Aug 19, 2019 Implants & Prosthetics Nationwide View Details →

BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

AZIYO BIOLOGICS

Class I - Dangerous

Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

Aug 21, 2019 Implants & Prosthetics Nationwide View Details →

CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

AZIYO BIOLOGICS

Class I - Dangerous

Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

Aug 21, 2019 Implants & Prosthetics Nationwide View Details →

Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Voco GmbH

Class I - Dangerous

The metal cannula are potentially too loose and may become loose when applying the filing material.

Jul 9, 2019 Implants & Prosthetics View Details →

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

Howmedica Osteonics

Class I - Dangerous

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

Aug 19, 2019 Implants & Prosthetics Nationwide View Details →

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:

Howmedica Osteonics

Class I - Dangerous

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

Aug 19, 2019 Implants & Prosthetics Nationwide View Details →
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