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.
Reported: October 2, 2024 Initiated: July 24, 2024 #Z-3264-2024
Product 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 for Recall
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Details
- Recalling Firm
- TMJ Solutions Inc
- Units Affected
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Location
- Ventura, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by TMJ Solutions Inc. Units affected: 1.
Why was this product recalled? ▼
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3264-2024.
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