Stryker medical implant recalled for manufacturing defect in barrier layer
Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a documented manufacturing defect affecting a critical implant component. No illnesses, injuries, or adverse events have been reported. The defect poses a potential risk of harm but has not resulted in patient injury, placing it in the High severity category.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling MEDPOR Titan OFW MTB Right 1.0mm implants (Catalog number 81032, UDI 07613252084334). A total of 74 units of this craniofacial implant were distributed worldwide and throughout the United States. The recall was initiated following discovery of a manufacturing defect in one of the distributed units.
The defective unit was found to have an incorrect placement of the barrier layer, a critical component of the implant. According to the product design, the barrier layer should be manufactured on the superior (upper) side of the implant. In the affected unit, the barrier layer was incorrectly manufactured on the inferior (lower) side instead.
No adverse events, patient injuries, or illnesses have been reported in connection with this defect. Patients and healthcare providers in possession of implants from Lot Number 3R7YHD should contact Stryker or their healthcare provider for further information and guidance.
The recalled product
- Product
- MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Hazard
- manufacturing-defect
- barrier-placement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 07613252084334
- Lot Number: 3R7YHD
Distribution
Distributed nationwide across the United States.
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