Recalls for Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
14 on file
- CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.TerminatedJun 28, 2022
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
- Biomet, Inc.TerminatedMar 8, 2016
Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. Oxidized components have failed cytotoxicity testing.
- Biomet, Inc.TerminatedApr 14, 2015
A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Zimmer Inc.TerminatedJun 30, 2009
Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Orthofix, IncTerminatedFeb 26, 2008
Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
- Immedica IncTerminatedJun 5, 2003
Mislabeled; wrong identification number on pin.
- Zimmer Biomet, Inc.TerminatedUnknown
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
- Zimmer Biomet, Inc.TerminatedUnknown
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws