Recall Z-2704-2017— Exactech, Inc.

Name: FDA recall Z-2704-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-07

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2017-04-07, terminated 2020-08-04. It names one FDA 510(k) clearance: K150890. Product: Exactech Optetrak Logic CC 15mm Tibial Augment Screws. Reason: Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-07
Terminated: 2020-08-04
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K150890 — Exactech Optetrak Logic CCExactech, Inc.·cleared 2015-05-29

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

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

Reason for recall

Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

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