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Zimmer, Inc. recalls Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from onco
Recalled January 29, 2014 · FDA recall Z-0783-2014 · Zimmer
Hazard
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. · FDA Class II
Units
5305 distribution events
Sold at
Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Description
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.
Product
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →