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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Recall Number Z-2119-2012
Classification Class II
Code Info Catalog Number 324-15-05 Serial Range 1620549-2381151
Product Distributed Qty 54,877 units for all products in Recall Event
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 shelf life.

Event Detail

Event Id 62566
Product Type Devices
Status Ongoing
Recalling Firm Exactech, Inc.
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.