Z-0519-2012

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

Name: Z-0519-2012 Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-07-26
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-07-26 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic on 2011-07-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0519-2012
Status: Terminated
Initiated: 2011-07-26
Posted: 2012-01-11
Terminated: 2016-06-10
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic.
Product code: FQO Table, Operating-Room, Ac-Powered
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
Root cause tag: design
FDA 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 in commerce: 52 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada and France.
Product codes and 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

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)