Jaw joint implants recalled over a discrepancy in screw hole position
TMJ Solutions is recalling 63 TMJ Bilateral Implants because the patient-fitted temporomandibular joint implant contained a discrepancy in screw hole position. The FDA classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The TMJ Bilateral Implant, REF CHG020, sterile EO and prescription only, from TMJ Solutions, is being recalled.
The patient-fitted temporomandibular joint implant contained a discrepancy in screw hole position.
The recall covers 63 units carrying UDIs including 07613327626551, 07613327626568 and 07613327626575. The product was distributed in Illinois, Oregon, Mississippi, Texas, Oklahoma, Utah, Massachusetts, Maryland, New York, Pennsylvania, Virginia, Florida, California, Minnesota and Georgia, and internationally to Canada, Spain and Brazil.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious injury or death. These implants are made to fit an individual patient, so a screw hole in the wrong position affects how the device seats in that person.
Facilities should quarantine affected stock immediately and follow the firm's instructions.
The recalled product
- Product
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
- Manufacturer
- TMJ Solutions Inc
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 07613327626551
- 07613327626568
- 07613327626575
- 07613327626605
Distribution
Related recalls
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Similar recalls
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FDA (Devices) · 2026-07-01
- HighStryker TMJ Unilateral Implant Recalled Due to Incorrect Components
FDA (Devices) · 2024-10-02
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
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- ModerateTMJ Solutions Recalls Misidentified Right Mandibular Component
FDA (Devices) · 2018-04-25
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement System
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- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
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