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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew SPIDER2 Limb Positioner

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  Class 2 Device Recall Smith & Nephew SPIDER2 Limb Positioner see related information
Date Initiated by Firm July 26, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-0519-2012
Recall Event ID 60518
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger
Catalog Number: 72203299.

Table, Operating-room, Pneumatic.
Code Information 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
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Same
978-749-1073
Manufacturer 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 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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