Recall Z-1862-2017— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-02-17, terminated 2018-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: various polyethylene implants Custom parts Product Usage: Custom. 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
Product description
various polyethylene implants Custom parts Product Usage: Custom
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.