Home / Recalls / Ebi, Llc / Z-1811-2014

Z-1811-2014 Class II Terminated

Recalled by Ebi, Llc — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
June 25, 2014
Initiation Date
May 15, 2014
Termination Date
April 21, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units (30 domestic and 2 international)

Product Description

Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

Reason for Recall

The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the country The Netherlands.

Code Information

Catalog Number 14-501669; Lot Number 006731

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