K-Wire Trochar Tip — Class II medical device recall Z-1948-2019
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-1948-2019 |
|---|---|
| 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 | 187764, 193497, 193567, 232280, 232683, 232684, 232685, 232686, 233858, 234049, 235477, BF10LJ8, BF10MAV, BFI0LJ8, BFI0LJ8R, BFI0M5B, BFI0MAV, BFI0MAVR, BFI0N16, BFI0NNN, BFIOLI8, I0N17, I0N18, I0NNN |
| Model numbers | 212000008 |
Product
K-Wire Trochar Tip, Model Number 212000008 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-1948-2019. 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.