FDA-Device2012-09-26Class II
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Biomet, Inc.
Hazard
Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Sold states
Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
Affected count
62
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2012Don't want to check this manually?
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