Recall Z-2120-2012— Exactech, Inc.

Name: FDA recall Z-2120-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2012-06-15, terminated 2013-07-03. It names one FDA 510(k) clearance: K103655. Product: Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).. Reason: Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Terminated: 2013-07-03
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K103655 — OCTANE-C INTERBODY FUSION DEVICE SYSTEMExactech, Inc.·cleared 2011-06-30

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

Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).

Reason for recall

Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

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