Recall Z-1863-2017— 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 2 FDA 510(k) clearances: K980665, K971938. Product: various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: 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
2 on FDA's record- K980665 — REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
- K971938 — REPICCI II UNICONDYLAR KNEE
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 Sports Med Repicci II Tibial Components Product Usage: 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.