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Terminated

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

FDA Recall Z-0519-2012 · Posted 2012-01-11

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeFQO
Date Initiated2011-07-26
Date Terminated2016-06-10
Product Quantity52 units

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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