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FDA Medical Device Recalls (openFDA)

Smith & Nephew Inc: Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152

Recall number
Z-1157-06
Recalling firm
Smith & Nephew Inc
Product
Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152
Status
Terminated
Initiated
2006-04-12
Posted
2006-06-17
Terminated
2007-04-11
Reason
Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.
Root cause
Other
Action
All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.
Quantity
3 units
Distribution
Worldwide-including states of LA, NC, IN, and countries of France, and Turkey
Lot, serial or model codes
05LM01939
510(k) numbers
not on file
PMA numbers
not on file
Product code
HSX
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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