BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Reported: November 27, 2013 Initiated: August 22, 2013 #Z-0359-2014
Product Description
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
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.
Details
- Recalling Firm
- Ebi, Llc
- Units Affected
- 7,092 units
- Distribution
- Nationwide distribution including Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system. Recalled by Ebi, Llc. Units affected: 7,092 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0359-2014.
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