Patient-Fitted Temporomandibular recall: Labeling Error
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ…
Why was Patient-Fitted Temporomandibular recalled?
This device was mislabeled and is not the correct component for this patient.
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?
Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
- Product
- Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ…
- Recalling firm
- TMJ Solutions Inc
- Quantity
- 1
- Distribution
- US Distribution to GA.
- Recall date
- April 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)