Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0872-2007

Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632...

Smith & Nephew, Inc. / initiated 2006-11-01 / Terminated / root cause: manufacturing process

Smith & Nephew, Inc Endoscopy Division began a recall of Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion... on . The reason FDA records is "The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0872-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Smith & Nephew, Inc.
Product
Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810.
Product code
NBH Accessories, Arthroscopic
Reason for recall
The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.
Quantity in commerce
12
Distribution
Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
Product codes and lots
Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.