Storz Phacoemulsification Needles

• 2 recalls, same reason

  • Terminated Z-1723-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2010
  • Terminated Z-1724-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2010

  Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

510(k) Number

K946176 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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See all devices from Storz Instrument Co. →