FDA recall Z-1961-2019

Product

Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

Reason for recall

Lack of an adequate sterilization validation.

Distribution

The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

Key facts

Status

Terminated

Initiation date

2019-06-10

Report date

2019-07-24

Termination date

2020-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2019