Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
FDA device recall Z-0652-2014 · posted 2014-01-09 · Terminated
Recall details
- Recalling firm
- ArthroCare Medical Corporation
- Reason for recall
- A sharp edge on the cannulated tip of the device may damage or cut a suture.
- Action taken
- All consignees were provided with written notice via Urgent Recall Notification dated December 9, 2013 with delivery confirmation. In addition, the firm plans on notifying the EU, and the governments of France, Germany, Switzerland, and Spain. The firm will also notify the Swedish government because the firm's EU representative is located in Sweden.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 76
- Distribution
- 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.
- Date initiated
- 2013-12-09
- Date posted
- 2014-01-09
- Date terminated
- 2015-04-08
- Location
- Austin, TX
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