Total Temporomandibular Joint Replacement System- 50mm recall
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Why was Total Temporomandibular Joint Replacement System- 50mm recalled?
Laser etching on the parts is wider and deeper than the conditions previously validated.
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?
Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B.
- Product
- Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
- Recalling firm
- Biomet Microfixation, LLC
- Quantity
- 42
- Distribution
- Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)