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Terminated

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

FDA Recall Z-2214-2013 · Posted 2013-09-17

Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-08-13
Date Terminated2015-03-11
Product Quantity427 units

Reason for Recall

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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