Class I - Dangerous
May contain small amounts of ethylene glycol residue
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 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
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 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
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 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
The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
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
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.