Octane-C Cervical recall: Labeling Error
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Why was Octane-C Cervical recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Sizes: 5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers
- Product
- Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
- Recalling firm
- Exactech, Inc.
- Quantity
- 54,877 units for all products in Recall Event
- Distribution
- 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.
- Recall date
- August 8, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)