Crosslock DVR ePAK -Sterile — Class II medical device recall Z-1082-2016
Terminated recall by Biomet, Inc., reported 2016-03-16, distributed nationwide. Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less tha
| Recall number | Z-1082-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-01-29 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, EC, JP, KR, NL, PA |
| Quantity | 21,268 |
| Reason classes | foreign material |
| Model numbers | 81180050 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.