Z-2563-2017 Class II Terminated
FDA device recall Z-2563-2017 was initiated by Zimmer Biomet, Inc. on February 28, 2017 and is designated Class II. Reason for recall: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. The recall status is terminated (terminated February 27, 2018). Affected quantity: 9867.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- February 28, 2017
- Termination Date
- February 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9867
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand