Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone l...
FDA Recall #Z-0783-2014 — Class II — December 19, 2013
Product Description
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Reason for Recall
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5305 distribution events
Distribution
Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Code Information
Part numbers 00-5850-012-95
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated