Recall Z-1114-2017 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
| Date | Jan 28, 2017 (initiated Dec 16, 2016) |
| Status | Terminated |
| Reason | labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection. |
| Root cause | Under Investigation by firm |
| Action | On 12/16/2016 and 12/21/2016, Zimmer Biomet contacted distributors via telephone to notify them of the issue and requested that the product be placed in a quarantine location to prevent use. On 12/22/2016 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and Risk Managers / Surgeons 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. Distributor responsibilities include: 1. Review this |
| Quantity | 16 |
| Distribution | WI NJ CA MD WA LA MA TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES Biomet Manufacturing Corp, Feb 13, 2009 |