Reported Nov 11, 2015 · Terminated
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Plantation, FL · 33317-7424
Is this the product you have?
- 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.
- Lot codes and dates
- Model/Catalog Numbers Affected
Mako Rio Robotic Arm (201000203999207300 and 209930
- Lot/Serial NumberAll RIO's
- Model/Catalog Numbers Affected
- Amount recalled
- 1,322 units
Where it was sold
Why it was recalled
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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