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U.S. Department of Health and Human Services

Class 2 Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis

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 Class 2 Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesissee related information
Date Initiated by FirmFebruary 11, 2026
Date PostedJune 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2524-2026
Recall Event ID 98509
PMA NumberP980052 
Product Classification Joint, temporomandibular, implant - Product Code LZD
ProductTMJ Bilateral Implants, REF: CHG020
Code Information UDI-DI: 07613327626575, Lot: 2508181038
FEI Number 3001237463
Recalling Firm/
Manufacturer		 TMJ Solutions Inc
6059 King Dr
Ventura CA 93003-7607
For Additional Information Contact
805-650-3391
Manufacturer Reason
for Recall		Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
FDA Determined
Cause 2		Process control
ActionOn 2/11/2026, the customer was contacted and verbally informed of the recall. On 4/23/2026, a recall notice was sent to the customer asking them to take the following action: 1) Inform all appropriate members of your organization who need to be made aware of this action. 2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. 3) Complete and return the Business Reply Form (BRF) via email to cmf-pfa@stryker.com Please contact the firm's quality department cmf-pfa@stryker.com with questions or concerns.
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of MA.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LZD
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