Ebi, Llc: Medical Device Recall in 2013 - (Recall #: Z-2214-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 13, 2013

Date Posted: September 25, 2013

Recall Number: Z-2214-2013

Event ID: 66098

Reason for Recall:

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

Status: Terminated

Product Quantity: 427 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated