Z-1858-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- February 17, 2017
- Termination Date
- January 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,253 in total
Product Description
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Reason for Recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Distribution Pattern
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
Code Information
Item 163005 Lot 309030