Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0359-2014 · Posted 2013-11-19

Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-08-22
Date Terminated2016-08-31
Product Quantity7,092 units

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.

Firm Action

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

Distribution Pattern

Nationwide distribution including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMBiomet Spine (Aka Ebi, LLC) · 2013-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑