MAKOplasty Hip Array Kit Laminate 150230
This recall has been terminated (originally issued November 25, 2015).
- Company
- Mako Surgical Corporation
- Recall Initiated
- November 25, 2015
- Terminated
- August 25, 2016
- Recall Number
- Z-1588-2016
- Quantity
- 10 units.
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
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
CO, KY, MN, WA and WV
Lot / Code Info
Catalog No. 210540, Lot Code: 150324
Root Cause
Component change control
Action Taken
On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.
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