Recall Z-0652-2014 ยท LXH Orthopedic Manual Surgical Instrument
ArthroCare Medical Corporation
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
| Date | Jan 9, 2014 (initiated Dec 9, 2013) |
| Status | Terminated |
| Reason | A sharp edge on the cannulated tip of the device may damage or cut a suture. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.