Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

FDA device recall Z-2581-2025 · posted 2025-09-17 · Open, Classified

Recall details

Recalling firm

Folsom Metal Products, Inc.

Reason for recall

Labeling includes shelf life that has not been validated.

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Open, Classified

Product code

GCZ

Quantity affected

490 units

Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.

Date initiated

2025-08-21

Date posted

2025-09-17

Location

Pelham, AL