Z-1295-03

T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S

Name: Z-1295-03 T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S
Creator: Stryker Howmedica Osteonics
Published: 2003-08-04
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-08-04 / Terminated

FDA source

Stryker Howmedica Osteonics began a recall of T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S on 2003-08-04. The reason FDA records is "The device does not have an oblong hole for dynamic locking as required". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1295-03
Status: Terminated
Initiated: 2003-08-04
Posted: 2003-10-15
Terminated: 2003-09-30
Recalling firm: Howmedica Osteonics Corp
Product: T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The device does not have an oblong hole for dynamic locking as required.
FDA root cause: Other
Action: Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
Quantity in commerce: 6
Distribution: The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
Product codes and lots: Lot K884459

Product code HSB

K003018Class IITitan Tibial NailHowmedica Osteonics Corp. / cleared 2000-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)