Device recall

Z-2214-2013: Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw…

FDA device recall · Class II · Ebi, Llc

Key facts

Recall number (Z-number) Z-2214-2013
Recall event 66098
Product 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
Product code LXH
Recalling firm Ebi, Llc
Recall class Class II
Status Terminated
Termination date Mar 11, 2015
FEI number 2242816

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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