Recall Z-0359-2014— Ebi, Llc

Name: FDA recall Z-0359-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Class II · Terminated

Class II FDA medical device recall by Ebi, Llc, initiated 2013-08-22, terminated 2016-08-31. It names one FDA 510(k) clearance: K123549. Product: 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: 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..

Recalling firm: Ebi, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Terminated: 2016-08-31
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMBiomet Spine (Aka Ebi, LLC)·cleared 2013-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.