Recall Z-0423-2015 ยท HWA Impactor
Zimmer, Inc.
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
| Date | Nov 24, 2014 (initiated Oct 14, 2014) |
| Status | Terminated |
| Reason | To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture. |
| Root cause | Labeling design |
| Action | On 10/14/2014, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-877-946-2761. |
| Quantity | 1165 units |
| Distribution | Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.