Class 2 Device Recall 16 mm Distraction Pin

• Date Initiated by Firm: August 21, 2025
• Date Posted: September 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2581-2025
• Recall Event ID: 97480
• Product Classification: Retainer, surgical - Product Code GCZ
• Product: Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
• Code Information: All lots distributed from August 1, 2020, to July 30, 2025/UDI:00850014548056
• Recalling Firm/ Manufacturer: Folsom Metal Products, Inc. ; 1449 Court Pl; Pelham AL 35124-1858
• For Additional Information Contact: Ms. Jennifer Martin; 205-733-0901
• Manufacturer Reason for Recall: Labeling includes shelf life that has not been validated.
• FDA Determined 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: 490 units
• Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.