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Recall Observatory FDA recall evidence

Device product

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

Z-0652-2014

December 09, 2013

Class II

Product summary

Firm
ArthroCare Medical Corporation
Event
Event 67087
Status
Terminated
Classification
Class II
Quantity
76
Official record key
device-enforcement:Z-0652-2014

Official wording

Reason: A sharp edge on the cannulated tip of the device may damage or cut a suture.

Code information: Catalog #25-3011, Lot #1049402

Distribution pattern: Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A sharp edge on the cannulated tip of the device may damage or cut a suture.