Z-0803-2018 Class II Terminated
FDA device recall Z-0803-2018 was initiated by Zimmer Biomet, Inc. on September 7, 2017 and is designated Class II. Reason for recall: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution. The recall status is terminated (terminated August 23, 2018). Affected quantity: 38,879 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- September 7, 2017
- Termination Date
- August 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,879 units
Product Description
The 2nd Assist Knee Positioner
Reason for Recall
Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
Distribution Pattern
Nationally
Code Information
Item# 740026