DVR Crosslock ePAK Screw Driver — Class II medical device recall Z-1946-2019
Terminated recall by Zimmer Biomet, Inc., reported 2019-07-10, distributed nationwide. There is a potential for weak seals of the sterile packaging.
| Recall number | Z-1946-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2019-07-04 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, JP, NL |
| Quantity | 3,022 total |
| Reason classes | sterility |
| Lot numbers | 187762, 193492, 193493, 193494, 193495, 193496, 193565, 225207, 235471, 235472, 235473, 235474, 235475, BF10LBJ, BFI0LBJ, BFI0M9E, BFI0N10, BFI0N11, BFI0P39, I0N0X, I0N0XR, I0N0Y, I0N10, I0N11, I0N5B, I0P39 |
| Model numbers | 212000002 |
Product
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Reason for recall
There is a potential for weak seals of the sterile packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1946-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.