2 — Class II medical device recall Z-0879-2020
Terminated recall by Synthes, Inc., reported 2020-02-05, distributed nationwide. There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube re
| Recall number | Z-0879-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-01-29 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 25 total |
| Reason classes | sterility |
| Lot numbers | 6L37877 |
| Model numbers | 04.210.110TS |
Product
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Reason for recall
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
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-0879-2020. 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.