Recall Z-2292-2013— Ebi, Llc

Name: FDA recall Z-2292-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-09

Class II · Terminated

Class II FDA medical device recall by Ebi, Llc, initiated 2013-04-09, terminated 2014-06-17. It names one FDA 510(k) clearance: K093629. Product: Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.. Reason: Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant..

Recalling firm: Ebi, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-04-09
Terminated: 2014-06-17
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K093629 — SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMBiomet Spine·cleared 2010-03-09

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

Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

Reason for recall

Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

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