Device product
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Z-3264-2024
Product summary
- Event
- Event 95139
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-3264-2024
Official wording
Reason: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Code information: Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Distribution pattern: US Nationwide distribution in the state of MN.
Derived failure modes
-
Unknown
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO