Device product
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Z-1459-2015
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 70722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112 devices
- Official record key
device-enforcement:Z-1459-2015
Official wording
Reason: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
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.
Derived failure modes
-
Unknown
Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.