Exactech, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1459-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

Product Classification:

Class II

Date Initiated: February 13, 2015
Date Posted: April 29, 2015
Recall Number: Z-1459-2015
Event ID: 70722
Reason for Recall:

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

Status: Terminated
Product Quantity: 112 devices
Code Information:

Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated