Stryker TMJ Unilateral Implant Recalled Due to Incorrect Components
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm product (surgical implant) where incorrect components were used in patient-fitted prostheses. The rubric identifies risk-of-harm products where injury has not yet been reported as Score 3.
Plain-English summary
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant (REF: GHG010) because patient-fitted temporomandibular prostheses were found to contain incorrect components.
The recalled implants were distributed nationwide. The recall involves Lot # 2403081022 (Order # 101432374). The device includes the Anatomical Bone Model, Glenoid Fossa Component (Right), and Mandibular Component (Right).
Patients who have received this implant should contact their healthcare provider immediately to confirm whether their device is affected and to discuss whether any corrective action is needed. Patients should have the lot number available when contacting their provider.
This is a Class II FDA recall. More information is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-3264-2024.
The recalled product
- 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.
- Manufacturer
- TMJ Solutions Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Order # 101432374 - Lot # 2403081022
- UDI: (01)07613327627800/(01)07613327625551
Distribution
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