Stryker Locking Screw — Class II medical device recall Z-2384-2020
Terminated recall by Stryker GmbH, reported 2020-06-24, distributed nationwide. Seal integrity of the blister pack may be compromised and sterility cannot be assured
| Recall number | Z-2384-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2020-05-07 |
| Classified | 2020-06-16 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2023-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CN, DE, DK, ES, FI, FR, GB, IE, IT, JP, LU, NL, NO, PL, PT, SE, ZA |
| Quantity | 400 |
| Reason classes | sterility, packaging |
| Lot numbers | K0207B3, K031B6B, K031B6C, K033439 |
| Model numbers | 18965040S |
Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Reason for recall
Seal integrity of the blister pack may be compromised and sterility cannot be assured
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-2384-2020. 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.