Recall Z-0536-2013 ยท HXX Screwdriver
Ebi, Llc
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
| Date | Dec 17, 2012 (initiated Sep 29, 2012) |
| Status | Terminated |
| Reason | Broken screw insertor hardness was measured and found to be below the acceptable limits. |
| Root cause | Process control |
| Action | Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012. |
| Quantity | 15 units |
| Distribution | Nationwide Distribution, including the states of MO, TX, and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.