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FDA Medical Device Recalls (openFDA)

Mitek Worldwide: Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030

Recall number
Z-0696-03
Recalling firm
Mitek Worldwide
Product
Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030
Status
Terminated
Initiated
2003-02-28
Posted
2003-04-01
Terminated
2004-02-04
Reason
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.
Root cause
Other
Action
Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.
Quantity
4
Distribution
CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
Lot, serial or model codes
Lot Number: 0301590
510(k) numbers
["K933738"]
PMA numbers
not on file
Product code
HWC
Firm FEI
not on file
Firm city
Norwood
Firm state
MA
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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