Recall Z-1861-2017— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-02-17, terminated 2018-01-29. It names 3 FDA 510(k) clearances: K060525, K042757, K040770. Product: various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.. Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-17
- Terminated
- 2018-01-29
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K060525 — VANGUARD REMOVABLE MOLDED POLY TIBIA
- K042757 — VANGUARD SSK KNEE SYSTEM
- K040770 — VANGUARD PATELLA COMPONENTS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
Reason for recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Data sourced from openFDA. This site is unofficial and independent of the FDA.