Reported Mar 25, 2020 · Terminated
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of…
Arthrex, Inc.
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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
- Lot codes and dates
- Product CodeAR-8545-20
- Batch Number10308261
- UDI00888867124424
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
Screws provided in the device package are 6 mm longer than intended.
This product could cause temporary or reversible health problems — stop using it.
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