Mako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues
Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Mako Surgical Corporation is voluntarily recalling 10,606 units of the Rio System Irrigation Clip (Catalog # 111690). The recall was initiated on May 10, 2018, and was classified as Class II by the FDA. The reason for the recall is that the affected clips are out of tolerance.
The affected product is used with the RESTORIS Partial Knee Application (PKA) for the Robotic Arm Interactive Orthopedic System (RIO). This system assists surgeons in providing software-defined spatial boundaries for orientation and reference information during orthopedic procedures, specifically unicondylar and patellofemoral knee replacements. The recall includes lots 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
The affected units were distributed nationwide in the United States and internationally in Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, the Netherlands, Singapore, and the United Kingdom. The recall status is terminated as of January 17, 2021. Mako Surgical Corporation notified customers via letter.
The recalled product
- Product
- Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and ref
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 10,606
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots #'s: 176364
- 178346
- 181337
- 185213
- 186561
- 189709
- 190559
- 193643
- and 195763A1.
Distribution
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