Z-1823-2019 Class II Terminated
FDA device recall Z-1823-2019 was initiated by Mako Surgical Corporation on April 25, 2019 and is designated Class II. Reason for recall: The bearings of the saw attachments were ungreased. The recall status is terminated (terminated April 22, 2021). Affected quantity: 39.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- April 25, 2019
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39
Product Description
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Reason for Recall
The bearings of the saw attachments were ungreased.
Distribution Pattern
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Code Information
Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918