Z-1493-2014 Class II Terminated
FDA device recall Z-1493-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on Mar 26, 2014 and is designated Class II. Reason for recall: During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal… The recall status is terminated (terminated Dec 11, 2014). Affected quantity: 35,310 unexpired units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 30, 2014
- Initiation Date
- Mar 26, 2014
- Termination Date
- Dec 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,310 unexpired 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, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
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-1493-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026