FDA recall Z-0940-2018

Product

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737

Reason for recall

Inner and outer sterile barriers not fully sealed.

Distribution

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

Key facts

Status

Terminated

Initiation date

2017-07-21

Report date

2018-03-21

Termination date

2020-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2018