—#105688

Product

Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic.

FDA product code: FQO — Table, Operating-Room, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada and France.

Timeline

Recall initiated: 2011-07-26
Posted by FDA: 2012-01-11
Terminated: 2016-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.