Reported Apr 27, 2022 · Completed
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Acumed 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: Acumed LLC · 5885 NW Cornelius Pass Rd · Hillsboro, OR · 97124-9370
Is this the product you have?
4.0mm x 10mm Cannulated ScrewShort ThreadPart number 3005-40010
- Lot codes and dates
- All Batch number distributed between 22 AUG 2018 to 07 FEB 2022
- UDI10806378022869
- Amount recalled
- 537 units
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
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
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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