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FDAFDA · Food and drugs·Recall number Z-1157-2016

Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF CR 13MM PLY R 3-9 42521000613 PSN ASF CR 13MM PLY R 7-1 42511000514 PSN ASF CR 14MM PLY L 3-1 42511000414 PSN ASF CR 14MM PLY L 3-9 42511000614 PSN ASF CR 14MM PLY L 7-1 42521000514 PSN ASF CR 14MM PLY R 3-1 42521000414 PSN ASF CR 14MM PLY R 3-9 42521000614 PSN ASF CR 14MM PLY R 7-1 42511000516 PSN ASF CR 16MM PLY L 3-1 42511000416 PSN ASF CR 16MM PLY L 3-9 42511000616 PSN ASF CR 16MM PLY L 7-1 42521000516 PSN ASF CR 16MM PLY R 3-1 42521000416 PSN ASF CR 16MM PLY R 3-9 42521000616 PSN ASF CR 16MM PLY R 7-1 42511000518 PSN ASF CR 18MM PLY L 3-1 42511000418 PSN ASF CR 18MM PLY L 3-9 42511000618 PSN ASF CR 18MM PLY L 7-1 42521000518 PSN ASF CR 18MM PLY R 3-1 42521000418 PSN ASF CR 18MM PLY R 3-9 42521000618 PSN ASF CR 18MM PLY R 7-1 42511400810 PSN ASF PS 10MM PLY L 10- 42511401010 PSN ASF PS 10MM PLY L 10- 42511400410 PSN ASF PS 10MM PLY L 3-5 42511400610 PSN ASF PS 10MM PLY L 3-5 42511400510 PSN ASF PS 10MM PLY L 6-9 42511400710 PSN ASF PS 10MM PLY L 6-9 42511400910 PSN ASF PS 10MM PLY L 6-9 42521400810 PSN ASF PS 10MM PLY R 10- 42521401010 PSN ASF PS 10MM PLY R 10- 42521400410 PSN ASF PS 10MM PLY R 3-5 42521400610 PSN ASF PS 10MM PLY R 3-5 42521400510 PSN ASF PS 10MM PLY R 6-9 42521400710 PSN ASF PS 10MM PLY R 6-9 42521400910 PSN ASF PS 10MM PLY R 6-9 42511400811 PSN ASF PS 11MM PLY L 10- 42511401011 PSN ASF PS 11MM PLY L 10- 42511400411 PSN ASF PS 11MM PLY L 3-5 42511400611 PSN ASF PS 11MM PLY L 3-5 42511400511 PSN ASF PS 11MM PLY L 6-9 42511400711 PSN ASF PS 11MM PLY L 6-9 42511400911 PSN ASF PS 11MM PLY L 6-9 42521400811 PSN ASF PS 11MM PLY R 10- 42521401011 PSN ASF PS 11MM PLY R 10- 42521400411 PSN ASF PS 11MM PLY R 3-5 42521400611 PSN ASF PS 11MM PLY R 3-5 42521400511 PSN ASF PS 11MM PLY R 6-9 42521400711 PSN ASF PS 11MM PLY R 6-9 42521400911 PSN ASF PS 11MM PLY R 6-9 42511400812 PSN ASF PS 12MM PLY L 10- 42511401012 PSN ASF PS 12MM PLY L 10- 42511400412 PSN ASF PS 12MM PLY L 3-5 42511400612 PSN ASF PS 12MM PLY L 3-5 42511400512 PSN ASF PS 12MM PLY L 6-9 42511400712 PSN ASF PS 12MM PLY L 6-9 42511400912 PSN ASF PS 12MM PLY L 6-9 42521400812 PSN ASF PS 12MM PLY R 10- 42521401012 PSN ASF PS 12MM PLY R 10- 42521400412 PSN ASF PS 12MM PLY R 3-5 42521400612 PSN ASF PS 12MM PLY R 3-5 42521400512 PSN ASF PS 12MM PLY R 6-9 42521400712 PSN ASF PS 12MM PLY R 6-9 42521400912 PSN ASF PS 12MM PLY R 6-9 42511400813 PSN ASF PS 13MM PLY L 10- 42511401013 PSN ASF PS 13MM PLY L 10- 42511400413 PSN ASF PS 13MM PLY L 3-5 42511400613 PSN ASF PS 13MM PLY L 3-5 42511400513 PSN ASF PS 13MM PLY L 6-9 42511400713 PSN ASF PS 13MM PLY L 6-9 42511400913 PSN ASF PS 13MM PLY L 6-9 42521400813 PSN ASF PS 13MM PLY R 10- 42521401013 PSN ASF PS 13MM PLY R 10- 42521400413 PSN ASF PS 13MM PLY R 3-5 42521400613 P

Published March 23, 2016 · Recall initiated: January 11, 2016

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

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Zimmer Manufacturing B.V.
Distributor
US Nationwide Distribution
Lot
lot no.: 61987247 62060580 62095143 62234779 62244505 62244506 61987260 62060581 62095146 62113095 62190263 62190265 62268839 62268840 62268841 62284790 62284791 62299465 62299466 62318794 62326957 62328734 62332491 62346392 62363051 62363053 62376636 61987268 62060583 62095147 62113090 62113101 62132939 62132940 62132942 62190289 62190290 62268834 62268835 62268836 62268837 62268838 62284788 62284789 62299453 62299454 62318790 62318791 62326952 62326953 62332486 62332487 62332488 62337857 62337858 62346390 62346391 62352421 62352422 62352423 62363042 62363044 62363045 62371750 62371751 62376627 62376631 62376633 62382635 61987269 62060584 62095150 62113092 62113103 62132943 62143610 62190260 62268830 62268831 62268832 62268833 62284792 62284793 62299457 62299458 62299463 62318792 62326954 62326955 62332489 62332490 62337859 62352425 62363048 62363050 62376624 62376625 62382629 62389123 62394482 62394483 62394484 62401095 61987271 62060585 62095151 62113096 62132944 62190283 62190284 62268828 62268829 62292643 62306253 62306254 62318793 62352426 62389121 61987272 62060587 62095153 62190261 62190262 62268826 62284786 62284787 62389120 62057581 62170314 62205011 62205012 62263791 62263793 62280365 62292713 62304377 62311612 62311613 62324380 62324381 62332145 62332147 62332148 62339521 62339522 62344471 62344472 62344473 62361825 62361827 62205003 62205004 62263779 62280357 62288230 62292710 62304364 62304365 62311601 62311602 62324354 62324356 62338066 62338067 62338068 62338069 62338070 62344464 62344465 62344466 62361858 62361859 62363541 62363542 62170316 62209947 62209948 62209949 62263830 62263831 62292723 62292724 62292725 62324395 62324396 62324397 62344478 62344479 62363549 62170327 62224706 62244583 62263967 62263969 62280317 62288190 62292692 62304402 62311634 62311637 62311643 62324470 62324471 62332151 62339547 62339548 62339549 62339560 62344597 62344598 62344599 62363534 62363535 62170321 62244738 62263928 62263930 62280321 62288192 62292693 62304388 62311622 62311623 62311624 62324455 62324456 62338080 62338081 62338082 62338083 62338084 62344587 62344588 62344589 62363543 62363544 62224704 62239774 62244745 62263982 62263983 62288175 62292671 62304407 62311655 62311658 62339553 62339554 62339555 62344610 62363634 62170315 62205013 62205014 62263795 62263796 62288212 62322795 62324382 62324383 62324384 62332150 62339523 62339524 62344474 62344475 62363507 62170311 62247401 62263781 62280335 62288206 62292697 62304366 62311603 62311604 62324357 62338071 62338072 62338073 62344467 62344468 62361840 62371343 62170317 62209951 62209952 62209953 62263892 62292720 62292722 62324398 62324399 62339526 62339527 62363545 62170328 62244741 62263970 62263971 62280333 62288203 62292696 62304404 62311647 62311648 62324472 62324473 62339550 62339551 62344602 62344603 62363512 62376815 62233517 62244560 62244561 62244748 62263932 62263933 62292669 62292670 62304391 62311625 62311626 62311627 62324457 62338085 62339545 62344590 62344591 62170333 62244743 62263984 62280329 62288199 62292695 62322346 62324485 62336943 62336944 62338088 62338089 62363581 62363582 62205016 62205017 62263797 62263798 62280354 62288228 62292709 62304378 62311614 62324385 62339525 62344477 62363509 62363510 62111675 62244585 62263783 62280344 62288209 62292701 62292702 62304367 62311607 62324369 62324370 62324371 62338074 62338075 62344469 62363524 62363525 62209954 62209955 62209956 62263893 62263894 62280361 62324401 62324402 62336945 62336946 62344487 62344488 62376776 62227835 62234758 62244590 62263972 62263973 62280285 62288177 62292675 62304405 62311649
Risk classification
Class II
Area (FDA)
device
Country
United States

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