Recall Z-0715-2022— Stryker Leibinger GmbH & Co. KG

Name: FDA recall Z-0715-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-29

Class II · Terminated

Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2021-12-29, terminated 2023-12-21. It names one FDA 510(k) clearance: K040364. 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..

Recalling firm: Stryker Leibinger GmbH & Co. KG
Classification: Class II
Status: Terminated
Initiated: 2021-12-29
Terminated: 2023-12-21
Firm location: Freiburg Im Breisgau, Germany

510(k) clearances named in this recall

1 on FDA's record

K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESHPorex Surgical, Inc.·cleared 2004-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.