Recall Z-1225-2012 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures.
| Date | Mar 19, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773). |
| Root cause | Packaging process control |
| Action | Smith & Nephew Endoscopy sent an "URGENT-PRODUCT RECALL 1st NOTIFICATION" dated February 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to inspect their inventory and quarantine any affected product. For instructions on returning product, contact the Smith & Nephew Endoscopy Division Returns Group at 800-343-5717 ( 0ption 3) or email to endo.andreturns@smith-nephew.com. Additionally, customers were asked to complete the bottom portion of the letter and to fax it to 1-508-261-3620. Con |
| Quantity | 194 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the states of AK, AZ, CA, CO, CT, IA , MD, MI, MN, MO, MS, NE, OH, OK, PA, SC, and VA and the countries of Australia, Canada, Germany, South Korea, Spain, Switzerland, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080358 | PLLA, HA SCREW Smith & Nephew Inc., Endoscopy Div., Apr 23, 2008 |