Z-1459-2015 Class II Terminated
FDA device recall Z-1459-2015 was initiated by Exactech, Inc. on Feb 13, 2015 and is designated Class II. Reason for recall: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. The recall status is terminated (terminated Sep 29, 2016). Affected quantity: 112 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 29, 2015
- Initiation Date
- Feb 13, 2015
- Termination Date
- Sep 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 devices
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.
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.
Code Information
Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1459-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026