FDA-Device2014-01-29Class II
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Zimmer, Inc.
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.
Sold states
Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Affected count
5305 distribution events
Manufactured in
345 E Main St, Warsaw, IN, United States
Products
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0783-2014Don't want to check this manually?
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