—#51542

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.

FDA product code: NBH — Accessories, Arthroscopic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.

Why it was recalled

The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc Endoscopy Division
Address: 76 S. Meridian Ave, Oklahoma City, Oklahoma 73107-6512

Distribution

Distribution pattern: Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK

Timeline

Recall initiated: 2006-11-01
Posted by FDA: 2007-06-06
Terminated: 2008-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.