Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /c
FDA device recall Z-1444-2018 · posted 2018-04-19 · Terminated
Recall details
- Recalling firm
- TMJ Solutions Inc
- Reason for recall
- This device was mislabeled and is not the correct component for this patient.
- Action taken
- TMJ Concepts sent an Medical Device Recall Communication letter dated March 12, 2018. INSTRUCTIONS: The implants for this case should not be used and should be immediately quarantined. We request that you return the entire case (the anatomical bone model together with both the fossa and mandibular components) to us by FedEx Priority Overnight Delivery. Any bone screws and drills that were provided with the shipment can be retained at your hospital and do not need to be returned. For further questions, please call (805) 650-3391.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LZD
- Quantity affected
- 1
- Distribution
- US Distribution to GA.
- Date initiated
- 2018-03-12
- Date posted
- 2018-04-19
- Date terminated
- 2019-07-23
- Location
- Ventura, CA
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