Class I - Dangerous
May contain small amounts of ethylene glycol residue
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat
regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Medtronic Inc. Cardiac Rhythm Disease Management
Class I - Dangerous
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Resource Optimization & Innovation
Class I - Dangerous
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
MicroPort Orthopedics
Class I - Dangerous
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Stryker Howmedica Osteonics
Class I - Dangerous
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
St Jude Medical Cardiac Rhythm Management Division
Class I - Dangerous
Some devices exhibit backup VVI operation due to a backup reset.