Recall archive
5 recalls · page 1 of 1
Reported May 24, 2017
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand · Product · Product details — Part of the number on the tray lid differ from the part number on the base.
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — Potential sterility deficiency.
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — Laser etching on the parts is wider and deeper than the conditions previously validated.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2014
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand · Product · Product details — Product mix occurred prior to final package and labeling process.
FDA (openFDA device enforcement)
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