Reported Jul 19, 2023 · Ongoing
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Osteomed, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Osteomed, LLC · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
- REF218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
- Lot codes and dates
Lot # 117702711777181177812 /
- UDI-DI(01)00845694034258
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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