Reported Jul 28, 2021 · Ongoing

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

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?

  • Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Lot codes and dates
  • Lots 12758314 and 13022357
Amount recalled
3985 pieces

Where it was sold

Why it was recalled

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

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, 7:32 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.