PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 29, 2015 Initiated: February 13, 2015 #Z-1459-2015

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Exactech, Inc.
Units Affected
112 devices
Distribution
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.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.. Recalled by Exactech, Inc.. Units affected: 112 devices.
Why was this product recalled?
Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 29, 2015. Severity: Moderate. Recall number: Z-1459-2015.