FDA recall Z-2051-2018

Product

Restoris MCK Onlay Insert Extractor.

Reason for recall

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

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.

Key facts

Status

Terminated

Initiation date

2018-01-19

Report date

2018-06-13

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2018