FDAClass IIMarch 9, 2022

MEDPOR Titan OFW - MTB - Right - 1.0mm recall

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

Why was MEDPOR Titan OFW - MTB - Right - 1.0mm recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 07613252084334; Lot Number: 3R7YHD

Product
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Recalling firm
Stryker Leibinger GmbH & Co. KG
Quantity
74
Distribution
Worldwide distribution - US Nationwide.
Recall date
March 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls