MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reported: March 15, 2017 Initiated: December 22, 2016 #Z-1411-2017
Product Description
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reason for Recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 777
- Distribution
- US nationwide distribution.
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.. Recalled by Mako Surgical Corporation. Units affected: 777.
Why was this product recalled? ▼
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1411-2017.
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