Biomet Spine, LLC
FDA Regulatory Profile
Biomet Spine, LLC appears in FDA public data with 14 recalls, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1253-2016, Class II) was initiated on February 12, 2016. Its most recent 510(k) clearance was granted on July 8, 2016.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1253-2016 | Class II | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. | February 12, 2016 |
| Z-0203-2016 | Class II | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Ante | September 29, 2015 |
| Z-2744-2015 | Class II | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lo | August 5, 2015 |
| Z-2759-2015 | Class II | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 an | July 22, 2015 |
| Z-1465-2015 | Class II | Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facili | March 12, 2015 |
| Z-2152-2015 | Class II | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, R | March 12, 2015 |
| Z-1466-2015 | Class II | Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterio | March 12, 2015 |
| Z-0982-2015 | Class II | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline | August 22, 2013 |
| Z-0978-2015 | Class II | Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 | August 22, 2013 |
| Z-0983-2015 | Class II | Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Later | August 22, 2013 |
| Z-1146-2015 | Class II | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to s | November 30, 2012 |
| Z-1069-2015 | Class II | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusabl | February 22, 2012 |
| Z-1089-2015 | Class II | Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provi | December 19, 2011 |
| Z-0220-2015 | Class II | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: | March 9, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152622 | Alta ACDF System | July 8, 2016 |
| K153695 | Biomet Spine Fusion System | January 21, 2016 |
| K151974 | Polaris Spinal System | November 13, 2015 |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral | August 12, 2015 |
| K151483 | Biomet Spine Fusion System | July 31, 2015 |
| K151224 | Lineum OCT Spine System | June 30, 2015 |
| K142634 | Biomet Spine Fusion System | March 12, 2015 |
| K141791 | BIOMET FUSION SYSTEM | October 9, 2014 |
| K141804 | POLARIS SPINAL SYSTEM - HA COATED | September 25, 2014 |
| K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS | June 15, 2012 |
| K112014 | ZYSTON STRAIGHT SPACER SYSTEM | October 17, 2011 |
| K103393 | POLARIS SPINAL SYSTEM | February 2, 2011 |
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM | March 9, 2010 |
| K091067 | 5.5 POLARIS SPINAL SYSTEM | July 14, 2009 |
| K082793 | INTERGRO DBM | April 2, 2009 |
| K081952 | SYNERGY SPINAL SYSTEM (6.35 POLARIS) | October 7, 2008 |
| K081636 | PEEK-OPTIMA ALIF SPACER | August 7, 2008 |
| K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM | July 2, 2008 |
| K081395 | SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM | June 25, 2008 |
| K080646 | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM | May 2, 2008 |