Recall Z-0519-2012 ยท FQO Table, Operating-Room, Ac-Powered
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic.
| Date | Jan 11, 2012 (initiated Jul 26, 2011) |
| Status | Terminated |
| Reason | SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage |
| Root cause | Device Design |
| Action | Smith & Nephew Advanced Surgical Devices Division sent an "URGENT- PRODUCT RECALL NOTIFICATION-URGENT" letter dated July 26, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. Customers were instructed to complete and return a form via fax at 405-917-8650. Contact the firm at 405-917-8556 for questions regarding this recall. |
| Quantity | 52 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.