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 Screw
    • Short Thread
    • Part 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:17 PM UTC

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