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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- ArthroCare Medical Corporation
- Hazard
- 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
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