Recall Z-2214-2013 ยท LXH Orthopedic Manual Surgical Instrument
Ebi, Llc
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
| Date | Sep 17, 2013 (initiated Aug 13, 2013) |
| Status | Terminated |
| Reason | Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. |
| Root cause | Device Design |
| Action | Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST. |
| Quantity | 427 units |
| Distribution | Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.