Z-2198-2017 Class II Terminated
FDA device recall Z-2198-2017 was initiated by Zimmer Biomet, Inc. on May 8, 2017 and is designated Class II. Reason for recall: Durability characteristics of reusable instruments were not established The recall status is terminated (terminated December 1, 2017). Affected quantity: Greater than 10,000,000 last 10 years.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- May 8, 2017
- Termination Date
- December 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Greater than 10,000,000 last 10 years
Product Description
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Reason for Recall
Durability characteristics of reusable instruments were not established
Distribution Pattern
Nationwide Worldwide
Code Information
All lots in distribution prior to 5/8/17