FDA recall Z-3019-2020

Exactech, Inc. · Class II · device

Product

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

Reason for recall

Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

Distribution

Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.

Key facts

Status
Terminated
Initiation date
2020-08-24
Report date
2020-10-07
Termination date
2023-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3019-2020