Recall Z-2493-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.
| Date | Sep 28, 2012 (initiated Sep 7, 2012) |
| Status | Terminated |
| Reason | Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have o |
| Root cause | Device Design |
| Action | Zimmer sent an Urgent Medical Device Recall dated August 2012 to distributors via electronic mail and Hospital risk managers and surgeons had notifications hand delivered by sales representatives. The recall notice describes the reason for the recall, emphasizes surgical technique to be used, includes instructions for delivering notifications to surgeons and risk managers, instructions for replacing the affected product, and instructions for returning the affected product. Customers were instructed to locate the affected product and contact their sales representative for replacement. Consign |
| Quantity | 60 |
| Distribution | Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc., Mar 27, 2012 |