Recall Z-2115-2012 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
| Date | Jul 31, 2012 (initiated Jun 15, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Labeling False and Misleading |
| Action | 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. Custome |
| 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, Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM Exactech, Inc., Oct 26, 2004 |