Recall Z-1219-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
| Date | Dec 15, 2016 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument. |
| Root cause | Material/Component Contamination |
| Action | Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument |
| Quantity | 26 |
| Distribution | Domestic: 0 Foreign: Singapore & Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142933 | Biomet Tibial trays Biomet, Inc., Dec 23, 2014 |