FDA recall Z-0715-2022

Stryker Leibinger GmbH & Co. KG · Class II · device

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.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status: Terminated
Initiation date: 2021-12-29
Report date: 2022-03-09
Termination date: 2023-12-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Freiburg Im Breisgau, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2022