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U.S. Department of Health and Human Services

Class 2 Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System

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  Class 2 Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System see related information
Date Initiated by Firm March 12, 2018
Date Posted April 19, 2018
Recall Status1 Terminated 3 on July 23, 2019
Recall Number Z-1444-2018
Recall Event ID 79614
PMA Number P980052 
Product Classification Joint, temporomandibular, implant - Product Code LZD
Product Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM

The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
Code Information Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
Recalling Firm/
Manufacturer		 TMJ Solutions Inc
2233 Knoll Dr
Ventura CA 93003-7398
For Additional Information Contact Mr. Gregory Rose
805-650-3391
Manufacturer Reason
for Recall		 This device was mislabeled and is not the correct component for this patient.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 1
Distribution US Distribution to GA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LZD and Original Applicant = TMJ CONCEPTS
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