ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Published February 26, 2014 · Recall initiated: October 11, 2013
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
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
- Lot
- 60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303 60172595 60203125 60208505 60293052 60293053 60385452 60435952 60451975 60513716 60550121 60569137 60621316 60653000 60671936 60690725 60700503 60783464 60820534 60860511 60860513 60860514 60922581 60931393 61057541 61057542 61091712 61144231 61144232 61175725 61179682 61213680 61213685 61226623 61458924 61496585 61496586 61516718 61652312 61987298 60931393R 60068461 60085970 60112862 60137583 60167084 60177165 60203127 60208506 60230633 60254680 60263992 60281385 60293054 60323227 60323228 60338339 60351950 60363732 60381044 60381045 60429147 60451979 60472802 60488988 60513720 60536838 60544315 60550122 60550123 60569139 60585209 60604065 60604067 60646729 60671937 60671938 60700504 60705398 60736738 60736739 60783465 60804583 60804584 60820535 60820536 60879653 60879654 60879655 60922582 60973810 61004373 61057265 61057267 61057528 61083833 61083835 61086989 61110816 61133147 61133148 61133149 61144233 61144234 61168198 61168199 61179683 61196070 61209047 61213689 61226624 61226625 61251155 61346007 61352916 61359836 61371148 61392581 61466852 61508368 61524260 61524261 61584950 61612575 61639615 61657718 61746169 61781850 61890428 61930475 61987301 62070014 62070016 62133640 60569139R 60700504R 61144234R 60063005 60106621 60111972 60132528 60137584 60155304 60167085 60172596 60177167 60186862 60198526 60198637 60218946 60218947 60218948 60242254 60245527 60254681 60263994 60263995 60281387 60293055 60293056 60309898 60309899 60323229 60323230 60338340 60338341 60363733 60367337 60367338 60381046 60381047 60385453 60393368 60423609 60425113 60435972 60435975 60451981 60451982 60472803 60479109 60487347 60488989 60513721 60528722 60536839 60536840 60550124 60569140 60569141 60576790 60585211 60585212 60597782 60604069 60604071 60621318 60621319 60621320 60646732 60646733 60646738 60653011 60653013 60671939 60671940 60671941 60700505 60700506 60705405 60705408 60736740 60736741 60757335 60757336 60757337 60783466 60783467 60804585 60804587 60807923 60820537 60820539 60820540 60820541 60870521 60879656 60879657 60879661 60922584 60925044 60925045 60925343 60943955 60958471 61004396 61004397 61004399 61004401 61057533 61057534 61057535 61057536 61072860 61083838 61083839 61086995 61091713 61095870 61095871 61110817 61133150 61135998 61136003 61141594 61141599 61141601 61141602 61151169 61151170 61151171 61168201 61168202 61168203 61196072 61198395 61198396 61213690 61213693 61213694 61224824 61226626 61226627 61245950 61251157 61256770 61273750 61310096 61310577 61346008 61357150 61371149 61378432 61390569 61392582 61392583 61447016 61453216 61473814 61484471 61491361 61508369 61508370 61508371 61516464 61567415 61612576 61612577 61620188 61639616 61652321 61652326 61657719 61663529 61700070 61720828 61740416 61758155 61781866 61818105 61831673 61862303 61882384 61930476 61930477 61964348 61987302 62093255 62093258 62093263 62171286 62292391 60052852 60057428 60063007 60111973 60132529 60137585 60155305 60162133 60167087 60169748 60186863 60190842 60198524 60198525 60198639 60203996 60208507 60218949 60218950 60230634 60242256 60242257 60245528 60263996 60263997 60263999 60281389 60293057 60293058 60309902 60309903 60323232 60323233 60338342 60351954 60351956 60367339 60381048 60381050 60385454 60393369 60423615 60425115 60435980 60451983 60455008 60472804 60479110 60488990 60488991 60488992 60513722 605137
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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