Device product
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Z-1863-2017
Product summary
- Event
- Event 76507
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,253 in total
- Official record key
device-enforcement:Z-1863-2017
Official wording
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Code information: Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150
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
Derived failure modes
-
Unknown
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.