Recall archive
245 recalls · page 11 of 11
Reported Sep 26, 2012
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 5, 2012
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Reason for recall — Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet U.K., Ltd.
Matched: Brand — A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but…
FDA (openFDA device enforcement)
Reported Aug 15, 2012
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details · Reason for recall — Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The…
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product details · Reason for recall — On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental…
FDA (openFDA device enforcement)
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