Recall Z-0201-2016— Exactech, Inc.

Name: FDA recall Z-0201-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-23

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2015-09-23, terminated 2017-03-01. It names one FDA 510(k) clearance: K080980. Product: Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation. Reason: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Terminated: 2017-03-01
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K080980 — EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMSExactech, Inc.·cleared 2008-05-06

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

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Reason for recall

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

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