Reported May 17, 2017 · Terminated

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

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?

  • Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Lot codes and dates
  • Unique Device Identifier00888867027329
  • Batch Number10072597 -
  • Expiration Date 10/31/2018 Batch Number10074288 -
  • Expiration Date 10/31/2018 Batch Number10076753 -
  • Expiration Date 10/31/2018 Batch Number10076852 -
  • Expiration Date 10/31/2018 Batch Number10081420 -
  • Expiration Date 11/30/2018 Batch Number10075965 -
  • Expiration Date 10/31/2018 Batch Number10077252 -
  • Expiration Date 10/31/2018 Batch Number10084027 - Expiration Date 12/31/2017
Amount recalled
N/A

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Some eyelets broke from SwiveLock Anchor on insertion.

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

Notice updated Nov 4, 2019 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.