Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299.

FDA device recall Z-0519-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

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

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.

Root cause

Device Design

Status

Terminated

Product code

FQO

Quantity affected

52 units

Distribution

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

Date initiated

2011-07-26

Date posted

2012-01-11

Date terminated

2016-06-10

Location

Andover, MA