Z-1261-2014 Class II Terminated
FDA device recall Z-1261-2014 was initiated by Zimmer, Inc. on Feb 25, 2014 and is designated Class II. Reason for recall: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as… The recall status is terminated (terminated Mar 24, 2015). Affected quantity: 3638 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 26, 2014
- Initiation Date
- Feb 25, 2014
- Termination Date
- Mar 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3638 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1261-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026