Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)
Unvalidated shelf life labeling may require product replacement.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Brand
Folsom Metal Products, Inc.
Lot Codes / Batch Numbers
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Products Sold
All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Folsom Metal Products, Inc. is recalling Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile due to Labeling includes shelf life that has not been validated.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling includes shelf life that has not been validated.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026