AXS PP — Class II medical device recall Z-2913-2018
Terminated recall by Stryker Leibinger GmbH & Co. KG, reported 2018-09-05, distributed in AZ, FL, NH, OH. After a three year term, there is a potential for the external packaging (sterile barrier) to become compromis
| Recall number | Z-2913-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, N/A, Germany |
| Recall initiated | 2018-06-22 |
| Classified | 2018-08-29 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2019-07-08 |
| Distributed | AZ, FL, NH, OH |
| Countries outside the US | AU, CA, FR, GB, NZ |
| Quantity | 22,831 total |
| Reason classes | sterility |
| Model numbers | 12-01544S |
Product
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Reason for recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
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-2913-2018. 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.