DVR Crosslock ePAK Depth Gauge — Class II medical device recall Z-1947-2019
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-1947-2019 |
|---|---|
| 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 | 187763, 193566, 226646, 230493, 231877, 232682, 235476, BF10LBK, BF10M9F, BFA012345, BFI0LBK, BFI0LBKR, BFI0M4H, BFI0M9F, BFI0N13, BFI0N14, BFION15, I0N12, I0N12R, I0N13 |
| Model numbers | 212000003 |
Product
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 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-1947-2019. 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.