Z-1696-2015 Class II Terminated
FDA device recall Z-1696-2015 was initiated by Zimmer, Inc. on Apr 30, 2015 and is designated Class II. Reason for recall: Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as… The recall status is terminated (terminated Mar 15, 2016). Affected quantity: 1,689.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 10, 2015
- Initiation Date
- Apr 30, 2015
- Termination Date
- Mar 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,689
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
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-1696-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026