Z-2118-2012 Class II Terminated
FDA device recall Z-2118-2012 was initiated by Exactech, Inc. on Jun 15, 2012 and is designated Class II. 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… The recall status is terminated (terminated Jul 3, 2013). Affected quantity: 54,877 units for all products in Recall Event.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2012
- Initiation Date
- Jun 15, 2012
- Termination Date
- Jul 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,877 units for all products in Recall Event
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2118-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026