FDA Enforcement
Class II
Ongoing
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.
Recall: Z-3264-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3264-2024
- Event ID
- 95139
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TMJ Solutions Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- October 2, 2024
- Initiation Date
- July 24, 2024
- Classification Date
- September 26, 2024
- Address
- 6059 King Dr, Ventura, CA, 93003-7607, United States
Description
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.
Reason
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Code Info
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Distribution
US Nationwide distribution in the state of MN.
Quantity
1