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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- TMJ Solutions Inc
- Reason for Recall:
- Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3264-2024
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TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
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Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
This device was mislabeled and is not the correct component for this patient.