FDAFDA · Food and drugs·Recall number Z-2214-2013
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
Published September 25, 2013 · Recall initiated: August 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ebi, Llc
- Distributor
- Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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