FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
- Recall number
- Z-1295-03
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
- Status
- Terminated
- Initiated
- 2003-08-04
- Posted
- 2003-10-15
- Terminated
- 2003-09-30
- Reason
- The device does not have an oblong hole for dynamic locking as required.
- Root cause
- Other
- Action
- Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
- Quantity
- 6
- Distribution
- The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
- Lot, serial or model codes
- Lot K884459
- 510(k) numbers
- ["K003018"]
- PMA numbers
- not on file
- Product code
- HSB
- 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
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