Z-0349-03

Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116

Name: Z-0349-03 Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Creator: Howmedica Osteonics Corp
Published: 2002-11-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2002-11-12 / Terminated

FDA source

Howmedica Osteonics Corp began a recall of Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116 on 2002-11-12. The reason FDA records is "Hip Stem Fractures in the neck area". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0349-03
Status: Terminated
Initiated: 2002-11-12
Posted: 2002-12-19
Terminated: 2003-04-04
Recalling firm: Howmedica Osteonics Corp
Product: Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Hip Stem Fractures in the neck area.
FDA root cause: Other
Action: Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Quantity in commerce: 16
Distribution: Product was distributed to hospitals and Howmedica Branch reps throughout the US.
Product codes and lots: Lot Codes: 1187701, 1233101, 1187701

Product code MEH

K993768Class IICitation Tmzf Ha StemHowmedica Osteonics Corp. / cleared 2000-01-21

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)