Recall Z-0519-2012
Smith & Nephew, Inc. Endoscopy Division · initiated July 26, 2011
Product
Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic.
Codes / lots: Serial Numbers: VAL07, VAL08,VAL11,VAL15, VAL16, VAL19, VAL20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 61, 62, 63, 66, 71, 73, 76, 77, 79, 80, 81, 82, 88, 90, 92, 93, 94, 95, 97, 98, 99, 100, 101, 102, 103, 104, 106, 107, 110
Reason for recall
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0519-2012
- Initiated
- July 26, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- June 10, 2016
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- 52 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and France.
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA