FDA Device recall Z-1082-2016
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The… by Biomet, citing 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-steriliz….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1082-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-29 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | All Lots. Part number: Description: 811810050 DVR EPAK EX NRW LOCK PLT RIGHT 811811040 DVR E…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 L |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1082-2016%22
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