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
This recall has been terminated (originally issued September 17, 2013).
- Company
- Ebi, Llc
- Recall Initiated
- August 13, 2013
- Posted
- September 17, 2013
- Terminated
- March 11, 2015
- Recall Number
- Z-2214-2013
- Quantity
- 427 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Distribution
Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
Lot / Code Info
14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021
Root Cause
Device Design
Action Taken
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.