Recalls / —

—#32562

Product

T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lot Code: K589039; K658262; K658259; K74990; K766542.

Why it was recalled

Targeting device may become distorted upon repeated autoclaving.

Root cause (FDA determination)

Other

Action the firm took

On March 31, 2004 recall letters and product accountability forms were sent via FedEx.

Recalling firm

Firm

Howmedica Osteonics Corp.

Address

300 Commerce Court, Mahwah, New Jersey 07430

Distribution

Distribution pattern

There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.

Timeline

Recall initiated

2004-03-31

Posted by FDA

2004-07-20

Terminated

2004-06-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32562. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.