Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 14 mm Distraction Pin

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall 14 mm Distraction Pinsee related information
Date Initiated by FirmAugust 21, 2025
Date PostedSeptember 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2580-2025
Recall Event ID 97480
Product Classification Retainer, surgical - Product Code GCZ
ProductFrontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Code Information All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032
Recalling Firm/
Manufacturer		 Folsom Metal Products, Inc.
1449 Court Pl
Pelham AL 35124-1858
For Additional Information ContactMs. Jennifer Martin
205-733-0901
Manufacturer Reason
for Recall		Labeling includes shelf life that has not been validated.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionOn 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.
DistributionUS Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.
Total Product Life CycleTPLC 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.
-
-