Recall Z-1082-2016
Biomet, Inc. · initiated January 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: All Lots. Part number: Description: 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…
Reason for recall
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.
FDA-determined cause: Package design/selection
Action taken
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated 1/29/2016 to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to immediately locate and remove the identified device(s); carefully follow instructions on enclosed Response Form; complete and return Response Form within three (3) business days via email to CPWARFieldAction@zimmerbiomet.com prior to return of product, use priority carrier for your shipment; if you have further distributed the product, you MUST notify hospital personnel of this action. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1082-2016
- Initiated
- January 29, 2016
- Posted by FDA
- March 8, 2016
- Terminated
- September 5, 2017
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Quantity
- 21,268
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.
- Recalling firm
- Biomet, Inc., Warsaw, IN