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Recall Observatory FDA recall evidence

Device product

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Z-0715-2022

December 29, 2021

Class II

Product summary

Firm
Stryker Leibinger GmbH & Co. KG
Event
Event 89458
Status
Terminated
Classification
Class II
Quantity
74
Official record key
device-enforcement:Z-0715-2022

Official wording

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.

Code information: UDI: 07613252084334; Lot Number: 3R7YHD

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.