Stryker Restoris RIO Reamer Handle recall
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in…
Why was Stryker Restoris RIO Reamer Handle recalled?
Failure of the Offset Cup Reamer Handle not engaging its mating components.
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?
All lots recalled, Catalog No. 207080.
- Product
- Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in…
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 595 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
- Recall date
- February 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)