Rio System Irrigation Clip recall
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive…
Why was Rio System Irrigation Clip recalled?
Out of tolerance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots #'s: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
- Product
- Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive…
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 10,606
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)