Recall Z-0158-2018— Exactech, Inc.

Name: FDA recall Z-0158-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-19

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2017-09-19, terminated 2021-06-21. It names one FDA 510(k) clearance: K023186. Product: Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.. Reason: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-19
Terminated: 2021-06-21
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K023186 — OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAYExactech, Inc.·cleared 2002-10-17

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

Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

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