Recall Z-1811-2014 ยท HXX Screwdriver
Ebi, Llc
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
| Date | Jun 17, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the produc |
| Quantity | 32 units (30 domestic and 2 international) |
| Distribution | Worldwide Distribution - USA (nationwide) and the country The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.