FDA-Device2014-06-25Class II

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

Ebi, Llc
Hazard

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

Sold states
Worldwide Distribution - USA (nationwide) and the country The Netherlands.
Affected count
32 units (30 domestic and 2 international)
Manufactured in
399 Jefferson Rd, N/A, Parsippany, NJ, United States
Products
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2014

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