Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Reported: November 11, 2015 Initiated: July 16, 2015 #Z-0224-2016
Product Description
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Reason for Recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 1,322 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
- Location
- Plantation, FL
Frequently Asked Questions
What product was recalled? ▼
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.. Recalled by Mako Surgical Corporation. Units affected: 1,322 units.
Why was this product recalled? ▼
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0224-2016.
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