Folsom Metal Products recalls 16mm Distraction Pins (Rx Only) with unvalidated shelf life labels. This affects products sold August 2020-July 2025. No remedy specified in official notice.
Labeling includes shelf life that has not been validated.
Folsom Metal Products is recalling 16mm Distraction Pins sold with unvalidated shelf life labels. This means the expiration date on the packaging may not be accurate, potentially leading to using expired medical devices.
The labeling includes a shelf life that hasn't been properly tested. This could mean the pins expire before the labeled date, but the risk is low since the pins are sterile and used only under medical supervision.
Patients prescribed these pins by doctors for spinal fusion procedures. Those using the product without medical supervision are not affected.
Check for the product name '16 mm Distraction Pin', 10 single packs, sold with a label showing a shelf life date. Products were distributed from August 1, 2020, to July 30, 2025.
Look for the shelf life date on the packaging; if it's unclear or unvalidated, contact your doctor.
The labeling includes a shelf life that hasn't been validated, meaning the expiration date may not be accurate.
No remedy is specified in the official notice, so you don't need to stop using it unless your doctor advises otherwise.
The official notice doesn't specify a remedy, so contact your doctor for guidance.
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-2581-2025 — Folsom Metal Products Folsom Metal Products Hello, I own a Folsom Metal Products that is covered by recall Z-2581-2025 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.
