—#111067

Product

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

FDA product code: ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K103655
Affected lot / code info: 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

Why it was 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

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832. For questions regarding this recall call 352-377-1140.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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.

Timeline

Recall initiated: 2012-06-15
Posted by FDA: 2012-07-31
Terminated: 2013-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111067. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.