various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Reported: April 26, 2017 Initiated: February 17, 2017 #Z-1863-2017
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 28,253 in total
- Distribution
- Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement. Recalled by Zimmer Biomet, Inc.. Units affected: 28,253 in total.
Why was this product recalled? ▼
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1863-2017.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11