MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
This recall has been terminated (originally issued November 3, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- September 29, 2015
- Posted
- November 3, 2015
- Terminated
- April 29, 2016
- Recall Number
- Z-0203-2016
- Quantity
- 17 units
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
Reason for Recall
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Distribution
US Distribution to the states of : NY, MO, and FL
Lot / Code Info
P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
Root Cause
Labeling mix-ups
Action Taken
Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious they are no longer functional. For further questions call (303) 443-7500 ext.244.