Recall Z-2059-2015— Exactech, Inc.

Name: FDA recall Z-2059-2015
Creator: U.S. Food and Drug Administration
Published: 2009-03-06

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2009-03-06, terminated 2015-07-14. It names one FDA 510(k) clearance: K051216. Product: Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.. Reason: Incorrect thread form on the screw..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2009-03-06
Terminated: 2015-07-14
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K051216 — HYDRALOK SYSTEMAltiva Corp.·cleared 2005-07-19

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

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

Reason for recall

Incorrect thread form on the screw.

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