FDA recall Z-1644-2018

Product

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Reason for recall

Incorrect product and/or label. Sizing is labeled incorrectly.

Distribution

AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam

Key facts

Status

Terminated

Initiation date

2017-12-01

Report date

2018-05-16

Termination date

2020-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2018