Z-0783-2014 Class II Terminated
FDA device recall Z-0783-2014 was initiated by Zimmer, Inc. on Dec 19, 2013 and is designated Class II. 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… The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 5305 distribution events.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 29, 2014
- Initiation Date
- Dec 19, 2013
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5305 distribution events
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.
Distribution Pattern
Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Code Information
Part numbers 00-5850-012-95
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0783-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026