Mako RIO Robotic System Components Recalled for Damaged Locking Pins
Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the product is a high-risk medical device used in surgical procedures. While no specific injuries are reported in the source text, the risk of harm from a damaged component during surgery warrants a High severity rating.
Plain-English summary
Mako Surgical Corporation is recalling specific components of the Robotic Arm Interactive Orthopedic (RIO) system, including the locking pin (PN#205143) and connector (PN# 112220). These components are indicated for use in surgical knee resurfacing and total hip arthroplasty joint replacement procedures.
The recall is being issued because the locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. The affected units include 1,322 devices distributed nationwide in the United States and in several international countries, including Italy, Japan, Germany, and Australia.
Healthcare providers and facilities should stop using the affected RIO system components immediately. Mako Surgical Corporation is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- 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.
- Manufacturer
- Mako Surgical Corporation
- Affected units
- 1,322
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 (3)
- Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000
- 203999
- 207300 and 209930. Lot/Serial Number: All RIO's.
Distribution
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