Recall Z-2086-2014— Exactech, Inc.

Name: FDA recall Z-2086-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-07

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2014-03-07, terminated 2014-08-04. It names one FDA 510(k) clearance: K042843. Product: NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.. Reason: The femoral stem is lacking specified plasma coating..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-07
Terminated: 2014-08-04
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K042843 — AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSAmbu, Inc.·cleared 2004-11-12

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 Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

Reason for recall

The femoral stem is lacking specified plasma coating.

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