The Recall Desk
HighFDA (Devices)·Z-0652-2014·Announced 2014-01-15

ArthroCare Knot Pusher Recalled Due to Sharp Edge Hazard

ArthroCare Medical Corporation is recalling 76 units of the SPORTS MEDICINE Knot Pusher because a sharp edge on the tip may damage or cut a suture.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the sharp edge may damage or cut a suture, but no injuries or illnesses have been reported in the source text.

Plain-English summary

ArthroCare Medical Corporation is recalling 76 units of the Arthrocare SPORTS MEDICINE Knot Pusher (REF 25-3011, LOT #1049402). The recall was initiated because a sharp edge on the cannulated tip of the device may damage or cut a suture.

The affected devices are non-sterile and prescription-only. They were distributed nationwide in the United States, including in California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, New York, Ohio, Texas, and Wisconsin. The devices were also distributed internationally to Canada, France, Germany, Spain, and Switzerland.

Healthcare providers and patients should stop using the affected devices and contact ArthroCare Medical Corporation for instructions on how to return them or obtain a replacement.

The recalled product

Product
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Affected units
76

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog #25-3011
  • Lot #1049402

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · ArthroCare Medical Corporation

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