Restoris MCK Onlay Insert Extractor recall
Restoris MCK Onlay Insert Extractor.
Why was Restoris MCK Onlay Insert Extractor recalled?
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
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?
Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope: Lot No. 19150517, 19160517.
- Product
- Restoris MCK Onlay Insert Extractor.
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 575 units total (400 US, 175 OUS)
- Distribution
- Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)