Z-1862-2017 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 Custom parts Product Usage: Custom
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
Items and lots: Item 110010452 732130 920720 Item 110010454 136510 Item 110010455 752320 896040 Item 110010456 383320 879930 Item 110010459 854290 879950 905350 Item 110010462 752460 778490 Item 110010468 827730 Item 110010476 827530 827540 Item 110010716 753050 ItemCP753453 655990 ItemCP753455 656110 ItemCP753461 382210 Item CP753470 436530 Item CP753476 502920 Item CP753478 524950 Item CP753480 436460 Item CP753486 655300 Item CP753488 655470 Item CP753494 467390 Item CP753496 467420 Item CP753502 448730 Item CP753504 453990 Item CP753506 454640 Item CP753508 502970 Item CP753510 831310 Item CP753512 654720 Item CP753514 594570 Item CP753517 594630 Item CP753519 534820 Item CP753521 535090 Item CP753523 654190 Item CP753525 674160 Item CP753531 691490 Item CP753533 691560 Item CP753535 691640 Item CP753537 691680 Item CP753547 691720 Item CP753549 696620