Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-58302
FDA device recall Z-2152-2015 · posted 2015-07-20 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
- Action taken
- Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 4,765 units
- Distribution
- Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
- Date initiated
- 2015-03-12
- Date posted
- 2015-07-20
- Date terminated
- 2015-12-21
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLARIS SPINAL SYSTEM (K133746) | Biomet Spine (Aka Ebi, LLC) | 2014-03-12 |