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FDAFDA · Food and drugs·Recall number Z-1861-2017

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

Published April 26, 2017 · Recall initiated: February 17, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Zimmer Biomet, Inc.
Distributor
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
Lot
Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 780710 780720 780730 780750 780760 Item 150478 240650 576750 576760 576770 576780 Item 159540 347930 373920 373940 456340 456350 545520 545530 Item 159541 341160 347940 347950 456370 456380 Item 159542 373970 442290 528600 Item 159543 293050 444990 Item 159544 347970 Item 159547 374010 456390 545540 661660 Item 159548 374020 374030 374040 456420 456430 545550 545560 661690 661710 877470 877480 Item 159549 176330 374050 528610 528620 582170 Item 159550 242070 374060 582190 Item 159551 293130 374080 Item 159552 374090 Item 159554 456460 661720 661730 707890 747790 747810 Item 159555 528650 528670 582240 917610 Item 159556 582270 Item 159557 582290 Item 159558 374190 Item 159562 374200 Item 159563 270530 Item 159564 456470 Item 159566 374210 Item 159568 341230 374220 374240 545570 545580 Item 159569 348040 348110 348120 374250 374260 917620 Item 159570 445000 445010 528740 Item 159571 348140 456520 Item 159575 374300 374320 374330 456530 456550 456560 545610 545620 Item 159576 170280 374350 374370 456570 545630 545640 661760 661780 Item 159577 170420 293190 374290 374420 528750 582360 582380 Item 159578 374430 Item 159579 456590 Item 159580 528760 Item 159582 456600 456610 661810 661830 661840 Item 159583 445020 445030 528780 Item 159584 528790 Item 159586 528810 Item 159592 445070 Item 159593 528830 Item 159595 170310 445080 Item 159790 348100 Item 159791 231520 445090 Item 159793 270610 Item 160790 293210 Item 160791 242190 Item 161034 780790 Item 161094 374630 Item 183400 375890 Item 183402 242200 Item 183406 172780 552200 552210 Item 183420 374660 374670 374680 374690 374700 374710 374740 374760 457930 457940 457950 528900 544200 544210 544220 578600 578630 578640 578680 578690 661030 Item 183421 293220 578710 Item 183422 293250 293290 374770 374780 374790 457970 457980 528910 544230 544250 578720 578730 578750 661090 Item 183424 172900 176780 293300 Item 183426 375900 Item 183440 231560 293320 293340 293350 374800 374810 374830 374840 374850 374870 374890 457990 458000 458020 458030 458040 458050 458060 458070 525080 525120 528940 528950 544300 572670 578800 578830 578910 748520 Item 183441 374900 Item 183442 173110 231640 293360 293370 293380 293390 374920 374940 374960 374980 458080 458090 458100 458110 458130 525530 527420 544320 544330 578920 578960 748570 932770 Item 183444 173120 176980 176990 293410 293420 293430 293450 458140 458150 544110 544130 544140 Item 183460 293500 293510 375000 375020 375050 375100 375120 375130 458160 458220 Item 183462 293540 375140 375160 458240 458250 Item 183464 177080 293570 293580 293600 458280 458300 458310 544160 544170 544180 Item 183466 293620 Item 183480 375930 Item 183481 241790 Item 183520 173290 376610 458320 458340 458350 528930 528960 579210 Item 183522 528980 579230 Item 183540 293640 293650 376660 376670 458360 458370 458380 528990 529000 529010 579260 645520 Item 183542 293660 529020 Item 183560 376690 376700 4
Risk classification
Class II
Area (FDA)
device
Country
United States

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