Recall Z-1318-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2016-03-09, terminated 2017-05-23. It names 2 FDA 510(k) clearances: K143543, K123907. Product: All instrumentation associated with the Prelude PF Resurfacing Knee System.. Reason: Inadequate design control..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-09
- Terminated
- 2017-05-23
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K143543 — Prelude PF Patellae
- K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF 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
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Reason for recall
Inadequate design control.
Data sourced from openFDA. This site is unofficial and independent of the FDA.