Patient-Fitted Temporomandibular recall
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Why was Patient-Fitted Temporomandibular recalled?
Device was shipped without having regulatory approval.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
- Product
- Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 1 unit
- Distribution
- Distribution of one unit only to a single customer in MA (USA)
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)