Z-0424-2015 Class II Terminated
FDA device recall Z-0424-2015 was initiated by Zimmer, Inc. on Oct 14, 2014 and is designated Class II. Reason for recall: To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad… The recall status is terminated (terminated Jun 9, 2015). Affected quantity: 4961 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 3, 2014
- Initiation Date
- Oct 14, 2014
- Termination Date
- Jun 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4961 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.
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-0424-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026