TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device distributed without regulatory clearance, representing a risk-of-harm scenario for a critical medical device. No injuries or illnesses have been reported, and distribution was limited to a single unit.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling one patient-fitted temporomandibular (TMJ) reconstruction prosthesis (Catalog #2208151054, Lot Number W67725). The device was shipped without FDA regulatory approval.
A medical device must receive FDA clearance before distribution to ensure it meets safety and effectiveness standards. This device did not complete that approval process before being shipped to a customer in Massachusetts.
Individuals who received this device should contact their healthcare provider immediately. Doctors and patients should verify the device's status and determine next steps for patient care.
The recalled product
- Product
- Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Category
- Medical Device
- Affected units
- 1
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 (3)
- TMJ Reconstruction Prosthesis
- Catalog #2208151054
- Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Distribution
Distributed in 1 state:
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