Recalls / —

—#115789

Product

Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306

Why it was recalled

Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.

Root cause (FDA determination)

Process control

Action the firm took

Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2012-12-20

Posted by FDA

2013-03-08

Terminated

2015-09-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #115789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.