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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66098
Product Type Devices
Status Ongoing
Recalling Firm Ebi, Llc
City Parsippany
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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 Class II Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. 427 units Z-2214-2013