FDA recall Z-1000-2020

Product

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

Reason for recall

The lot contained two outer pins instead of one outer and one inner pin.

Distribution

Distributed to accounts in California and Ohio.

Key facts

Status

Terminated

Initiation date

2019-12-12

Report date

2020-02-12

Termination date

2021-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2020