Recall Z-2119-2012— Exactech, Inc.

Name: FDA recall Z-2119-2012
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: K102951. Product: Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.. 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

K102951 — EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)Exactech, Inc.·cleared 2010-11-04

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

Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

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.