Biomet Microfixation, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 29
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2073-2017 | Class II | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | April 11, 2017 |
| Z-2751-2016 | Class II | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR | June 13, 2016 |
| Z-0136-2016 | Class II | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. | August 6, 2015 |
| Z-0137-2016 | Class II | Thinflap System Case The cases hold surgical instrumentation in place during handling and storage. | August 6, 2015 |
| Z-0519-2015 | Class II | Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the t | October 17, 2014 |
| Z-0513-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the tem | October 17, 2014 |
| Z-0510-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the | October 17, 2014 |
| Z-0512-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the t | October 17, 2014 |
| Z-0509-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | October 17, 2014 |
| Z-0518-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the | October 17, 2014 |
| Z-0511-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temp | October 17, 2014 |
| Z-0522-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the te | October 17, 2014 |
| Z-0516-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the t | October 17, 2014 |
| Z-0517-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the te | October 17, 2014 |
| Z-0514-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the | October 17, 2014 |
| Z-0520-2015 | Class II | Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the te | October 17, 2014 |
| Z-0521-2015 | Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the t | October 17, 2014 |
| Z-0515-2015 | Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temp | October 17, 2014 |
| Z-2566-2014 | Class II | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The | September 20, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241709 | Pectus Blu Support Bar System | September 19, 2024 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | November 15, 2022 |
| K212782 | SternaLock Sternal Closure System | May 17, 2022 |
| K212608 | RibFix Blu Thoracic Fixation System | April 22, 2022 |
| K213712 | Pectus Support Bar System | March 11, 2022 |
| K213208 | Twist Drills | December 23, 2021 |
| K202969 | Biomet Microfixation OmniMax MMF System | August 5, 2021 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | June 5, 2019 |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | December 9, 2016 |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | November 23, 2016 |
| K161896 | Biomet Microfixation Sternal Closure System | August 2, 2016 |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | March 24, 2016 |
| K152326 | Biomet Microfixation OmniMax MMF System | December 10, 2015 |
| K151019 | SternaLock® 360 Sternal Closure System | November 3, 2015 |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | May 26, 2015 |
| K143336 | Biomet Microfixation OmniMax MMF System | April 1, 2015 |
| K142823 | Biomet Microfixation Thoracic Fixation System | February 25, 2015 |
| K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | October 2, 2013 |
| K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | August 8, 2013 |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | June 17, 2013 |