FDA Device recall Z-0715-2022
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 by Stryker Leibinger And Kg, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0715-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-29 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Leibinger And Kg |
| Distribution | US |
Product
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Reason
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.
Identifiers
| code_info | UDI: 07613252084334; Lot Number: 3R7YHD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0715-2022%22
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