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FDA Medical Device Recalls (openFDA)

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.

Recall number
Z-0872-2007
Recalling firm
Smith & Nephew, Inc Endoscopy Division
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.
Status
Terminated
Initiated
2006-11-01
Posted
2007-06-06
Terminated
2008-06-16
Reason
The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
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
12
Distribution
Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
Lot, serial or model codes
Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
510(k) numbers
not on file
PMA numbers
not on file
Product code
NBH
Firm FEI
1643264
Firm city
Oklahoma City
Firm state
OK
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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