M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
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
- 368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248 61332792 61727932 368490 60158049 60506370 60741224 60960320 61111054 61120925 61143374 61220140 61298509 61143374R 368281 60114142 60232597 60518286 60960628 60960818 61220141 61266215 61281313 61317747 60175525 60281124 60958453 60960815 61140792 61159204 61275565 61317749 60960815R 61275565R 368311 368493 60082894 60281333 61075889 61111055 61159205 61220142 61290251 61338952 368112 368494 60186975 60253467 60703526 60994877 61075890 61111056 61143376 61220143 61275566 60186975R 60253467R 60703526R 368284 368285 368948 60082895 60186976 60305055 60958452 60960816 61140794 61271223 61281317 61313785 367853 368496 60376357 60506371 60725289 61075891 61140795 61237562 61281322 61298511 61468151 60506371R 60725289R 368324 368497 60082896 60484441 61020656 61075892 61117767 61220144 61294524 61501046 00368497R 60082896R 368286 368498 60158050 60484442 60718439 61237563 61266214 61294525 61367353 00368498R 60158050R 60484442R 60718439R 61266214R 368287 60186977 61140796 61267607 61290253 61341154 00368287R 60186977R 61140796R 368288 60186978 61178912 61307949 61501047 00368500R 60186978R 61178912R 61501047R 368312 61178913 61317751 61328162 61317751R 368313 60186979 61143378 61211142 61228027 61290256 61328163 00368313R 61211142R 61290256R 368289 60158051 60919031 61275568 00368289R 60158051R 368113 60165694 60677567 60919032 61117768 61140797 61317753 61338953 61428547 367341 368114 60591981 61075893 61117769 61140799 61155653 61237564 61249763 61281323 61453188 61501049 61249763R 61501049R 368115 60591982 61049751 61075894 61114076 61140801 61206020 61214454 61220913 61290257 61501052 61049751R 367183 367833 60214950 60338296 60771516 60931843 61075895 61114077 61117770 61140802 61155654 61214458 61220922 60771516R 368116 60114143 60136484 60186980 60422981 60553621 60640168 60735561 61111057 61143379 61206022 61303817 61338954 368117 60114144 60154554 60338297 60348768 60573173 60758081 60815082 60972651 61112102 61133048 61206021 61220914 61453189 60348768R 368118 368508 60104629 60177401 60214951 60325612 60621819 60931805 60958455 60960817 61075896 61111058 61140803 61228032 00368508R 60104629R 60123507R 60958455R 367771 367854 60093774 60139921 60177402 60401281 60487360 60537981 60582853 60747471 60806257 60931901 61049745 61049746 61075904 61111059 61120926 61206024 61220920 61313786 60806257R 61111059R 365769 60123509 60173849 60219049 60253469 60367703 60506372 60573175 60591986 60684961 60735562 60944278 60973785 61049748 61049750 61075905 61111060 61114078 61228031 61237565 61271219 61313792 60123509R 367184 367344 367823 60119119 60138857 60173850 60219050 60269621 60401282 60582854 60621822 60679608 60820242 60931806 60931807 61049737 61049739 61049742 61111061 61155655 61172928 61220924 61276759 61281324 61458979 61556949 60173850R 60582854R 61155655R 365770 367824 367825 60119120 60241736 60338298 60534411 60561204 60582856 60621823 60679607 60684962 60820244 61111062 61172913 61234890 61260903 61276760 61290262 61468152 61542211 00365770R 00367824R 60679607R 61172913R 61260903R 367307 367856 60123511 60241740 60338299 60348773 60566317 60582857 60591988 60645760 60784479 60784480 61049729 61111063 61133050 61143380 61220923 61275569 61281325 61303819 61338955 61382441 61468153 61764008 00367307R 60501479R 60582857R 60591988R 61468153R 368119 368120 368513 60621824 60732930 60789383
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.