Z-1588-2016 Class II Terminated
FDA device recall Z-1588-2016 was initiated by Mako Surgical Corporation on November 25, 2015 and is designated Class II. Reason for recall: Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product ta… The recall status is terminated (terminated August 25, 2016). Affected quantity: 10 units..
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- November 25, 2015
- Termination Date
- August 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units.
Product Description
MAKOplasty Hip Array Kit Laminate 150230
Reason for Recall
Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
Distribution Pattern
CO, KY, MN, WA and WV
Code Information
Catalog No. 210540, Lot Code: 150324