Z-1962-2019 Class II Terminated
FDA device recall Z-1962-2019 was initiated by Zimmer Biomet, Inc. on June 4, 2019 and is designated Class II. Reason for recall: The products do not have sufficient data to support the labeled shelf life of 10 years. The recall status is terminated (terminated July 21, 2021). Affected quantity: 8478 total.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 4, 2019
- Termination Date
- July 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8478 total
Product Description
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Reason for Recall
The products do not have sufficient data to support the labeled shelf life of 10 years.
Distribution Pattern
Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Code Information
Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825