Recalls / —

—#25131

Product

Citation TMZF HA Hip Stem Left (Femoral Hip Prosthesis) Catalog No. 6265-5106

FDA product code

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K993768

Affected lot / code info

Lot Codes: 1148401, 1176101, 1176102, 1205001

Why it was recalled

Hip Stem Fractures in the neck area.

Root cause (FDA determination)

Other

Action the firm took

Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.

Recalling firm

Firm

Howmedica Osteonics Corp

Address

359 Veterans Blvd, Rutherford, New Jersey 07070

Distribution

Distribution pattern

Product was distributed to hospitals and Howmedica Branch reps throughout the US.

Timeline

Recall initiated

2002-11-12

Posted by FDA

2002-12-19

Terminated

2003-04-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.