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Restoris MCK Onlay Insert Extractor recallZ-2051-2018 · Mako Surgical Corporation · initiated Jan 19, 2018

Class II Terminated All recalls posted in June 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mako Surgical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

FDA root cause category: Under Investigation by firm

What the company is doing

Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.

Recall details

Recall number
Z-2051-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 19, 2018
Posted by the FDA
Jun 1, 2018
Recalling firm
Mako Surgical Corporation
Quantity
575 units total (400 US, 175 OUS)
Product code
NPJ
FDA submissions
K090763
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.

Product description

Restoris MCK Onlay Insert Extractor.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

68 devices cleared under K090763 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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