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FDA Medical Device Recalls (openFDA)

Howmedica Osteonics Corp: Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116

Recall number
Z-0349-03
Recalling firm
Howmedica Osteonics Corp
Product
Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Status
Terminated
Initiated
2002-11-12
Posted
2002-12-19
Terminated
2003-04-04
Reason
Hip Stem Fractures in the neck area.
Root cause
Other
Action
Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Quantity
16
Distribution
Product was distributed to hospitals and Howmedica Branch reps throughout the US.
Lot, serial or model codes
Lot Codes: 1187701, 1233101, 1187701
510(k) numbers
["K993768"]
PMA numbers
not on file
Product code
MEH
Firm FEI
2219689
Firm city
Rutherford
Firm state
NJ
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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