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FDA Medical Device Recalls (openFDA)

Stryker Howmedica Osteonics Corp.: Long Length Dyax Nail.

Recall number
Z-0256-06
Recalling firm
Stryker Howmedica Osteonics Corp.
Product
Long Length Dyax Nail.
Status
Terminated
Initiated
2004-09-07
Posted
2005-12-01
Terminated
2006-10-03
Reason
Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
Root cause
Other
Action
The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.
Quantity
4
Distribution
The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
Lot, serial or model codes
Catalog No. 1594-4430S Lot K559623
510(k) numbers
["K013468"]
PMA numbers
not on file
Product code
NDH
Firm FEI
3003070421
Firm city
Mahwah
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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