Z-2578-2025Class II

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Name: Z-2578-2025 Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Creator: Folsom Metal Products, Inc.
Published: 2025-08-21
License: https://open.fda.gov/license/

Folsom Metal Products, Inc. / initiated 2025-08-21 / Open, Classified / root cause: labeling and UDI

FDA source

Folsom Metal Products, Inc. began a recall of Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile on 2025-08-21. FDA classified it as Class II and gives the reason as "Labeling includes shelf life that has not been validated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2578-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-21
Posted: 2025-09-17
Recalling firm: Folsom Metal Products, Inc.
Product: Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Product code: GCZ Retainer, Surgical
Reason for recall: Labeling includes shelf life that has not been validated.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 2,700 units
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Product codes and lots: All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2578-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2576-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2577-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2578-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2579-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2580-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17
Z-2581-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-17

Product code GCZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)