MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate
FDA device recall Z-0203-2016 · posted 2015-11-03 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 17 units
- Distribution
- US Distribution to the states of : NY, MO, and FL
- Date initiated
- 2015-09-29
- Date posted
- 2015-11-03
- Date terminated
- 2016-04-29
- Location
- Broomfield, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K133518) | Biomet Spine (Aka Ebi, LLC) | 2014-11-05 |
| C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K080646) | Biomet Spine | 2008-05-02 |