Notice names this product. TMJ Solutions’s TMJ Bilateral Implants is named in FDA Class II recall Z-2524-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: UDI-DI: 07613327626575, Lot: 2508181038. Units affected: 1. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
TMJ Bilateral Implants
Company / brand
TMJ Solutions
Lot / serial / date codes
UDI-DI: 07613327626575, Lot: 2508181038
Distribution
US Nationwide distribution in the state of MA.
Agency product description and boundaries
TMJ Bilateral Implants, REF: CHG020
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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.