Reported Apr 20, 2016 · Terminated
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for…
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?
- Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
- Lot codes and dates
- Unique Device Identifier
00888867131446Catalog No.: AR-8918CPBatch No.: 10020303
- Unique Device Identifier
- Amount recalled
- 117 devices
Where it was sold
Why it was recalled
Potential for a component contained in the Implant System to be non-sterile.
This product could cause temporary or reversible health problems — stop using it.
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