Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation

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.

LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222;

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.

TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-65. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-67. TransFx drill bits can

Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.