Recall Z-2577-2025 ยท GCZ Retainer, Surgical
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
| Date | Sep 17, 2025 (initiated Aug 21, 2025) |
| Status | Open, Classified |
| Reason | Labeling includes shelf life that has not been validated. |
| Root cause | Incorrect or no expiration date |
| Action | On August 21, 2025, Frortier Devices issued a "Urgent: Medical Device Recall" Notification to affected consignees via FedEx. On August 22, 2025, Frontier reissued the notification to correct an incorrect product number. Frontier asked consignees to take the following actions: 1. Immediately examine your inventory and quarantine any affected units. 2.If you have affected units: Return product to Frontier Devices at the address listed, OR Destroy product on-site and complete the enclosed Certificate of Destruction Form. 3. If you may have further distributed this product, please identify your c |
| Quantity | 160 units |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.