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FDA Medical Device Recalls (openFDA)

Plus Orthopedics USA: Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807

Recall number
Z-0924-05
Recalling firm
Plus Orthopedics USA
Product
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Status
Terminated
Initiated
2005-06-03
Posted
2005-06-22
Terminated
2005-07-13
Reason
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
Root cause
Other
Action
Notification was made by telephone beginning June 2, 2005. Recall is on-going.
Quantity
54 USA 78 Europe
Distribution
Idaho, Texas and Virginia
Lot, serial or model codes
Lot / Unit Code: 044152
510(k) numbers
["K022204"]
PMA numbers
not on file
Product code
JWH
Firm FEI
3001237832
Firm city
San Diego
Firm state
CA
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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