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.
FDA Recall Z-0872-2007 · Posted 2007-06-06
Recalling FirmSmith & Nephew, Inc Endoscopy Division
Recall StatusTerminated
Product CodeNBH
Date Initiated2006-11-01
Date Terminated2008-06-16
Product Quantity12
Reason for Recall
The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.