Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
FDA Recall #Z-0919-2013 — Class II — December 20, 2012
Product Description
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Reason for Recall
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Recalling Firm
Stryker Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
48 units
Distribution
Nationwide Distribution.
Code Information
Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated