Drug recall
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA recall event 89458 · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Event ID | 89458 |
|---|---|
| Recall numbers | Z-0715-2022 |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Product type | Devices |
| Products | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 29, 2021 |
| Report date | Mar 9, 2022 |
| Termination date | Dec 21, 2023 |
| City | Freiburg Im Breisgau |
| Country | Germany |
| FEI number | 3002821504 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: