Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10… recallZ-2576-2025 · Folsom Metal Products, Inc. · initiated Aug 21, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Folsom Metal Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Labeling includes shelf life that has not been validated.

FDA root cause category: Incorrect or no expiration date

What the company is doing

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 customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please share this notice with all users within your organization. If the product has been transferred to a different facility, please make them aware of the notice. 4. Complete and return the enclosed Medical Device Recall Response Acknowledgment Form as soon as possible, even if no affected product remains in your possession. Please have them complete the acknowledgement response form and return it to you.

Recall details

Recall number: Z-2576-2025
Status: Open, Classified
Initiated by the company: Aug 21, 2025
Posted by the FDA: Sep 17, 2025
Recalling firm: Folsom Metal Products, Inc.
Quantity: 3790 unit
Product code: GCZ
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.

Product description

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Code information (models, lots, serial numbers)

All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548001

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

12mm Distraction Pin 301.912S1
Folsom Metal Products, Inc. · Retainer, Surgical
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 97480).

Z-2577-2025 · Open, Classified
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Z-2578-2025 · Open, Classified
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Z-2579-2025 · Open, Classified
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Z-2580-2025 · Open, Classified
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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