Safety Alert: Class II: Labeling includes shelf life that has not been validated.
healthClass IIRecalled on Sep 24, 2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
🔢 490 units
Sold At: Folsom Metal Products, Inc.(US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.)
Recall #: FDA-DEVICE-Z-2581-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- All lots distributed from August 1, 2020, to July 30, 2025/UDI:00850014548056
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Summary
Labeling includes shelf life that has not been validated.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Folsom Metal Products, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.