CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Medpor Titan OFW - MTB - Right recalled by Stryker Leibinger GmbH & Co.
Stryker Leibinger GmbH & Co. KG is recalling Medpor Titan OFW - MTB - Right, distributed nationwide in the US. The recall was initiated on 29 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0715-2022
- FDA event ID
- 89458
- Recalling firm
- Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Dec 2021
- FDA classified
- 3 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 29 Dec 2021 | Recall initiated by company | |
| 3 Mar 2022 | Classified by FDA | +64 days |
| 9 Mar 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: 07613252084334; Lot Number: 3R7YHD
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Leibinger GmbH & Co. KG
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 8000-021-002, Scopis¿ ENT recalled by Stryker Leibinger GmbH & Co. | Stryker Leibinger GmbH & Co. KG | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Dynamic Mesh- Std-medium-Intended recalled | Stryker Leibinger GmbH & Co. KG | Labeling Errors | Nationwide |
| Device | CLASS II | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis recalled | Stryker Leibinger GmbH & Co. KG | Other | MA |
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