Z-2760-2019 Class II Terminated
FDA device recall Z-2760-2019 was initiated by Howmedica Osteonics Corp. on August 19, 2019 and is designated Class II. Reason for recall: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component The recall status is terminated (terminated May 6, 2020). Affected quantity: 159 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- August 19, 2019
- Termination Date
- May 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.