Reported Mar 16, 2016 · Terminated
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
- Lot codes and dates
- All Lots
- Part numberDescription: 811810050 DVR EPAK EX NRW LOCK PLT RIGHT 811811040 DVR EPAK NRW MINI LOCK PLT R 811811050 DVR EPAK NRW LOCK PLT R 811812040 DVR EPAK MINI LOCK PLT R 811812050 DVR EPAK DIST VLR PT STD R 811812060 DVR EPAK DISTAL VLR PLT MED RT 811812090 DVR EPAK DISTAL PLT LONG RT 811812125 DVR EPAK EXT LONG LOCK PLT R 811812175 DVR EPAK EX-EXT LONG LK PLT R 811813050 DVR EPAK WIDE LOCK PLT R 811814050 DVR EPAK VOLAR RIM PLATE RIGHT 811815050 DVR EPAK VOLAR RIM NRW PLT RT 811817050 DVR EPAK DORSAL PLATE STD RT 811817150 DVR EPAK DORSAL PLATE WIDE RT 811818060 DVR EPAK RADIAL PLT STD RIGHT 811818160 DVR EPAK RADIAL PLATE WIDE RT 811820050 DVR EPAK EX NRW LOCK PLT LEFT 811821040 DVR EPAK NRW MINI LOCK PLT L 811821050 DVR EPAK NRW LOCK PLT L 811822040 DVR EPAK MINI LOCK PLT L 811822050 DVR EPAK LOCK PLT L 811822060 DVR EPAK MEDIUM LOCK PLT L 811822090 DVR EPAK LONG LOCK PLT L 811822125 DVR EPAK EXT LONG LOCK PLT L 811822175 DVR EPAK EX-EXT LONG LK PLT L 811823050 DVR EPAK WIDE LOCK PLT L 811824050 DVR EPAK VOLAR RIM PLATE LEFT 811825050 DVR EPAK VOLAR RIM NRW PLT LT 811827050 DVR EPAK DORSAL PLATE STD LEFT 811827150 DVR EPAK DORSAL PLATE WIDE LT 811828060 DVR EPAK RADIAL PLATE STD LEFT 811828160 DVR EPAK RADIAL PLATE WIDE LT 811839050 DVR EPAK ULNA PLATE BILATERAL 811899001 DVR EPAK RIGHT DNI 811899002 DVR EPAK LEFT DNI 811899003 EPAK DVR C/LCK VOLR RIM RT DNI 811899004 EPAK DVR C/LCK VOLR RIM LT DNI 811899005 EPAK DVR DORSAL PLATE RT DNI 811899006 EPAK DVR DORSAL PLATE LT DNI 811899007 EPAK DVR RDL COLUMN PLT RT DNI 811899008 EPAK DVR RDL COLUMN PLT LT DNI 811899009 EPAK DVR ULNA PLT BILAT DNI 811911050 DVR EPAK NRW LOCK PEG RT 811912050 DVR EPAK LOCK PEG RT 811913050 DVR EPAK WIDE LOCK PEG RT 811921050 DVR EPAK NRW LOCK PEG LT 811922050 DVR EPAK LOCK PEG LT 811923050 DVR EPAK WIDE LOCK PEG LT 811999001 DVR EPAK PEG RIGHT DNI 811999002 DVR EPAK PEG LEFT DNI
- Amount recalled
- 21,268
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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