Biomet Microfixation, LLC
Complete recall history across all FDA and CPSC categories — 19 total recalls
Biomet Microfixation, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (19)
FDA medical device enforcement actions by Biomet Microfixation, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 11, 2017 | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Part of the number on the tray lid differ from the part number on the base. | Class II |
| Jun 13, 2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... | Potential sterility deficiency. | Class II |
| Aug 6, 2015 | Thinflap System Case The cases hold surgical instrumentation in place during... | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opene... | Class II |
| Aug 6, 2015 | Neuro Combo Set Case The cases hold surgical instrumentation in place during... | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opene... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand R... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand R... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Re... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand ... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Rec... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Rec... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Oct 17, 2014 | Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand R... | Laser etching on the parts is wider and deeper than the conditions previously... | Class II |
| Sep 20, 2013 | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa... | Product mix occurred prior to final package and labeling process. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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