Recall Z-1895-2012 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Zimmer, Inc.
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
| Date | Jun 27, 2012 (initiated May 12, 2012) |
| Status | Terminated |
| Reason | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. |
| Root cause | Mixed-up of materials/components |
| Action | Zimmer sent URGENT DEVICE REMOVAL NOTIFICATION emails to distributors on May 12, 2012 to remove the product from all locations in their territories. This was an initial notification to prevent further distribution and use of the product. Zimmer Inc. sent follow-up notifications dated June 7, 2012 to the distributors, surgeons and hospital user accounts describing the product issue and providing recommended actions. Customers were directed to (877) 946-2761 for assistance or questions. |
| Quantity | 87 units |
| Distribution | Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM Zimmer GmbH, Mar 15, 2011 |