FDA Medical Device Recalls (openFDA)
Folsom Metal Products, Inc.: Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Recall number
- Z-2576-2025
- Recalling firm
- Folsom Metal Products, Inc.
- Product
- Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
- Status
- Open, Classified
- Initiated
- 2025-08-21
- Posted
- 2025-09-17
- Terminated
- not on file
- 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 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
- 3790 unit
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
- Lot, serial or model codes
- All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCZ
- Firm FEI
- 3006803588
- Firm city
- Pelham
- Firm state
- AL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28