Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mode
FDA device recall Z-3264-2024 · posted 2024-09-26 · Open, Classified
Recall details
- Recalling firm
- TMJ Solutions Inc
- Reason for recall
- Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- Action taken
- On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- LZD
- Quantity affected
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Date initiated
- 2024-07-24
- Date posted
- 2024-09-26
- Location
- Ventura, CA
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