MEDPOR Titan OFW — Class II medical device recall Z-0715-2022
Terminated recall by Stryker Leibinger GmbH & Co. KG, reported 2022-03-09, distributed nationwide. Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barr
| Recall number | Z-0715-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, Germany |
| Recall initiated | 2021-12-29 |
| Classified | 2022-03-03 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 74 |
| UPC / GTIN / UDI-DI | 07613252084334 |
| Lot numbers | 3R7YHD |
| Model numbers | 81032 |
Product
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Reason for recall
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
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-0715-2022. 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.