Disposable Paper Filter for Sterilization Containers Paper — Class II medical device recall Z-0114-2016
Terminated recall by Stryker Craniomaxillofacial Division, reported 2015-10-14. Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability o
| Recall number | Z-0114-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Craniomaxillofacial Division, Portage, MI, United States |
| Recall initiated | 2015-09-17 |
| Classified | 2015-10-08 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-02-26 |
| Countries outside the US | CA, CH, DE, FR, IT, JP, NL, NO, SE |
| Quantity | 915 packages |
| Reason classes | sterility |
| Model numbers | 29-10911 |
Product
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
Reason for recall
Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
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-0114-2016. 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.