ClearanceBrief
Recall Z-0872-2007 ยท NBH Accessories, Arthroscopic

Smith & Nephew, Inc Endoscopy Division

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.

DateJun 6, 2007 (initiated Nov 1, 2006)
StatusTerminated
ReasonThe device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
Root causeOther
ActionFirm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.
Quantity12
DistributionNationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.