Z-1081-2019 Class II Terminated
FDA device recall Z-1081-2019 was initiated by Zimmer Biomet, Inc. on February 28, 2019 and is designated Class II. Reason for recall: Lack of an adequate sterilization validation The recall status is terminated (terminated April 23, 2020). Affected quantity: 89 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2019
- Initiation Date
- February 28, 2019
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Product Description
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Reason for Recall
Lack of an adequate sterilization validation
Distribution Pattern
Nationwide
Code Information
All lots