BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobil
FDA device recall Z-0359-2014 · posted 2013-11-19 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- Reason for recall
- Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
- Action taken
- Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 7,092 units
- Distribution
- Nationwide distribution including Puerto Rico.
- Date initiated
- 2013-08-22
- Date posted
- 2013-11-19
- Date terminated
- 2016-08-31
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (K123549) | Biomet Spine (Aka Ebi, LLC) | 2013-02-25 |