Folsom Metal Products recalls 14mm Distraction Pins (Rx Only) with unvalidated shelf life labels. These medical devices may expire before use due to untested labeling.
Labeling includes shelf life that has not been validated.
Folsom Metal Products recalls 14mm Distraction Pins sold with unvalidated shelf life labels. This could mean the pins expire before use, risking ineffective treatment for patients needing spinal surgery.
The shelf life label on these pins hasn't been tested by the manufacturer. This means the pins might expire before they're needed, potentially leading to ineffective treatment if used after expiration.
Patients prescribed these pins for spinal surgery and healthcare providers who use them. The risk is low because the pins are only for medical use under a prescription.
Check for the product name '14 mm Distraction Pin', 5 single packs, and the unique identifier 00850014548032. These were sold from August 1, 2020, to July 30, 2025.
Look for the unique identifier 00850014548032 on the packaging to confirm if your pins are recalled.
The recall is due to unvalidated shelf life labels, not safety issues. They are safe if used before expiration, but the label may be inaccurate.
Check for the unique identifier 00850014548032 on the packaging. These pins were sold from August 1, 2020, to July 30, 2025.
The recall record does not specify a return or disposal action, so no action is required beyond checking the product details.
We’ve drafted a message you can send Folsom Metal Products to request your refund or repair — edit it as you like.
Subject: Recall Z-2578-2025 — Folsom Metal Products Folsom Metal Products Hello, I own a Folsom Metal Products that is covered by recall Z-2578-2025 from Folsom Metal Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.