Ebi Trochanteric Nail System

• • Terminated Z-1819-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

• • Terminated Z-1478-2012 FDA Not yet classified ·initiated 30 Mar 2012

  The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation

• • Terminated Z-0012-06 FDA Unclassified (pre-2012) ·initiated 24 Jun 2005 ·on shared 510(k) K050118

  Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K050118 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Ebi, L.P. →