Recall Z-1917-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
| Date | Jun 7, 2016 (initiated May 11, 2016) |
| Status | Terminated |
| Reason | Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. |
| Root cause | Component design/selection |
| Action | Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. |
| Quantity | 10,256 |
| Distribution | Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM Zimmer, Inc., Nov 7, 2012 |