CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Stryker TMJ Unilateral Implant recalled by TMJ Solutions
TMJ Solutions is recalling Stryker TMJ Unilateral Implant, distributed nationwide in the US. The recall was initiated on 24 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3264-2024
- FDA event ID
- 95139
- Recalling firm
- TMJ Solutions, Ventura, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2024
- FDA classified
- 26 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2024 | Recall initiated by company | |
| 26 Sep 2024 | Classified by FDA | +64 days |
| 2 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of MN.
Questions about this recall
Is Stryker TMJ Unilateral Implant recalled?
Yes. TMJ Solutions recalled Stryker TMJ Unilateral Implant on 24 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-3264-2024.
Why was it recalled?
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Which lots are affected?
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Where was it sold?
US Nationwide distribution in the state of MN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TMJ Solutions
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TMJ Bilateral Implants recalled by TMJ Solutions | TMJ Solutions | Other | Nationwide |
| Device | CLASS I | TMJ Bilateral Implant recalled by TMJ Solutions | TMJ Solutions | Sterility | 15 states |
| Device | CLASS II | Patient-Fitted Temporomandibular recalled by TMJ Solutions | TMJ Solutions | Labeling Errors | GA |
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