Recall Z-2744-2015 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Biomet Spine, LLC
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
| Date | Sep 9, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| Reason | Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page |
| Quantity | 7 parts |
| Distribution | Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080646 | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM Biomet Spine, May 2, 2008 |