| | Class 2 Device Recall TMJ Unilateral Implants |  |
| Date Initiated by Firm | July 24, 2024 |
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| Date Posted | September 26, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3264-2024 |
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| Recall Event ID |
95139 |
| Product Classification |
Joint, temporomandibular, implant - Product Code LZD
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| 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. |
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| Code Information |
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551 |
Recalling Firm/
Manufacturer |
TMJ Solutions Inc
6059 King Dr
Ventura CA 93003-7607
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| For Additional Information Contact | Katharina Feige-G¿tz
805-650-3391 |
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Manufacturer Reason
for Recall | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO |
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FDA Determined
Cause 2 | Mixed-up of materials/components |
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| Action | On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device. |
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| Quantity in Commerce | 1 |
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| Distribution | US Nationwide distribution in the state of MN. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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