[pending] TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Pending LLM rewrite. Source: FDA_DEVICE Z-0488-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
The recalled product
- Product
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
- Manufacturer
- TMJ Solutions Inc
- Category
- Medical Device — Devices
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
Distributed in 15 states:
- CA
- FL
- GA
- IL
- MA
- MD
- MN
- MS
- NY
- OK
- OR
- PA
- TX
- UT
- VA
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