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FDA Medical Device Recalls (openFDA)

Smith & Nephew Inc: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

Recall number
Z-0862-2007
Recalling firm
Smith & Nephew Inc
Product
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146
Status
Terminated
Initiated
2007-03-13
Posted
2007-06-07
Terminated
2011-10-28
Reason
The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Root cause
Other
Action
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
Quantity
1 unit
Distribution
Europe. No domestic distribution.
Lot, serial or model codes
Lot Number: 64803
510(k) numbers
not on file
PMA numbers
["P040033"]
Product code
LXH
Firm FEI
1020279
Firm city
Memphis
Firm state
TN
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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