Z-0639-2018 Class II Terminated
FDA device recall Z-0639-2018 was initiated by Zimmer Biomet, Inc. on May 1, 2017 and is designated Class II. Reason for recall: Robot arm being sent to the wrong position The recall status is terminated (terminated July 13, 2020). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- May 1, 2017
- Termination Date
- July 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Reason for Recall
Robot arm being sent to the wrong position
Distribution Pattern
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Code Information
SP16008