Class 2 Device Recall Zimmer

• Date Initiated by Firm: January 11, 2016
• Date Posted: March 12, 2016
• Recall Status: Terminated on April 13, 2017
• Recall Number: Z-1135-2016
• Recall Event ID: 72900
• 510(K)Number: K965098
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Product 37 consists of all product under product code: HSB and same usage:; Item no: ; 225302055 INTERLOCKING IM SCREW LG; 225303055 INTERLOCKING IM SCREW LG; 225304055 INTERLOCKING IM SCREW LG; 225304555 INTERLOCKING IM SCREW LG; 225305055 INTERLOCKING IM SCREW LG; 225305555 INTERLOCKING IM SCREW LG; 225306055 INTERLOCKING IM SCREW LG; 225306555 INTERLOCKING IM SCREW LG; 225307055 INTERLOCKING IM SCREW LG; 225307555 INTERLOCKING IM SCREW LG; 225308055 INTERLOCKING IM SCREW LG; 225308555 INTERLOCKING IM SCREW LG; 225309055 INTERLOCKING IM SCREW LG; 225302542 INTERLOCKING IM SCREW MED; 225303042 INTERLOCKING IM SCREW MED; 225303542 INTERLOCKING IM SCREW MED; 225304042 INTERLOCKING IM SCREW MED; 225304542 INTERLOCKING IM SCREW MED; 225305042 INTERLOCKING IM SCREW MED; 225305542 INTERLOCKING IM SCREW MED; 225306042 INTERLOCKING IM SCREW MED; 225306542 INTERLOCKING IM SCREW MED; 225307042 INTERLOCKING IM SCREW MED; 225307542 INTERLOCKING IM SCREW MED; 225308042 INTERLOCKING IM SCREW MED; 225308542 INTERLOCKING IM SCREW MED; 225302037 INTERLOCKING IM SCREW SML; 225302537 INTERLOCKING IM SCREW SML; 225303037 INTERLOCKING IM SCREW SML; 225303537 INTERLOCKING IM SCREW SML; 225304037 INTERLOCKING IM SCREW SML; 225304537 INTERLOCKING IM SCREW SML; 225305037 INTERLOCKING IM SCREW SML; 225305537 INTERLOCKING IM SCREW SML; 225306037 INTERLOCKING IM SCREW SML; 225306537 INTERLOCKING IM SCREW SML; 225308537 INTERLOCKING IM SCREW SML; ; Product Usage:; An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
• Code Information: lot no.: 61906265 61764344 61764345 61763538 61804376 61804377 61804378 61809821 61843699 61889644 61912613 61920742 61934239 61934254 61934264 61934275 61968078 61983673 62005552 62021122 62038732 62165487 62165488 62188649 62188650 62253382 62253386 61709145 61763552 61763553 61804388 61841501 61881343 61889662 61912626 61920743 61934285 61934286 61934287 61934288 61993619 62005554 62021123 62038746 62121122 62121123 62176083 62176084 62188636 62253396 62253398 62298584 61809822 61821684 61839142 61876353 61876354 61876355 61876356 61878893 61889664 61908098 61908099 61908101 61908103 61968079 61968080 61979092 62027386 62027387 62027388 62027389 62075773 62075774 62075775 62075776 62075781 62075782 62075785 62075786 62075792 62075803 62075804 62075805 62075806 62075807 62121136 62121139 62121141 62121146 62188652 62188654 62188655 62188658 62188659 62188661 62188662 62188663 62262078 61665049 61729658 61763551 61809823 61809824 61836999 61859423 61859425 61859426 61859427 61859428 61859429 61859430 61878766 61878780 61908104 61934289 61934290 61968081 61979095 61993623 62005555 62038756 62102479 62102480 62102481 62102482 62102483 62102484 62102485 62102486 62102502 62102504 62102518 62102520 62102521 62102522 62102523 62102524 62102525 62102526 62102528 62102529 62102530 62102531 62102532 62137923 62137924 62165524 62165525 62165526 62165528 62165529 62165531 62165532 62165533 62165534 61665051 61729660 61763513 61809826 61809827 61836991 61836992 61836993 61855506 61855507 61855508 61855519 61855521 61855524 61855528 61872543 61872544 61872545 61878784 61940664 61940667 61940670 61979097 61979099 62009852 62009853 62027390 62027391 62122328 62122329 62122330 62122331 62122332 62122333 62122334 62122335 62122337 62122340 62122573 62160813 62160815 62194667 62194668 62194670 62194671 62237301 62237304 62237306 62237308 62237311 62242582 62248997 62248998 62249001 62249002 61665053 61729665 61763517 61763518 61809828 61830467 61830468 61841505 61859453 61859455 61859456 61859458 61859459 61859503 61859506 61859508 61881381 61881383 61912627 61938030 61938034 61938036 61938056 61983696 61983700 62008169 62008170 62027392 62027393 62038758 62038763 62056691 62056694 62056695 62056696 62056697 62056698 62056699 62056701 62056702 62056703 62056704 62056705 62056706 62056707 62056708 62121063 62121065 62121067 62242583 61729669 61729670 61729671 61752999 61809829 61809830 61809831 61841506 61841507 61859519 61859520 61859521 61859522 61859523 61878895 61878897 61889665 61889666 61954842 61954843 61954844 61954845 61954846 61968084 62021124 62021128 62021139 62027394 62027395 62038765 62121166 62121167 62142040 62142041 62182671 62182674 62182675 62182676 62182680 62182694 62182712 62319581 61597043 61621183 61729672 61763523 61809832 61809833 61841508 61841509 61865224 61865225 61865226 61865227 61865229 61865244 61865251 61865252 61865253 61878787 61893775 61908105 61908106 61908107 61912631 61912632 61964027 61964029 61964030 61964031 61964033 62021141 62021142 62021154 62033060 62038766 62038767 62109283 62109284 62109285 62126010 62126012 62126013 62126014 62126015 62126017 62126018 62126019 62126020 62126022 62133392 62133393 62133394 62142044 62142045 62220565 62220566 62220567 62220568 62220569 62220570 62220572 62220574 62236303 62236305 62236307 62236308 62236309 62236313 62236314 62236316 62236317 62236319 62244439 62285844 62332667 61621184 61729673 61729674 61763524 61809834 61809835 61851385 61851387 61851389 61865648 61865649 61865650 61865651 61878806 61936597 61936598 61936599 61936600 61949227 61949228 61949229 61964043 61964044 61964045 61964046 61968083 62021163 62021164 62037802 62038774 62038776 62121002 62121005 62121006 62121008 62121012 62121014 62121017 62121022 62121023 62121024 62121025 62121026 62121027 62142037 62142038 62172494 62172497 62172503 62172504 62172505 62172506 62172508 62172509 62172510 62172513 62234067 62234068 62234069 62234070 62234071 62234072 62234073 62234074 62234075 62234076 62236301 62250620 62250621 62250622 62253410 62285839 62285839N 61597052 61621185 61729676 61753007 61800191 61841510 61878785 61878786 61893776 61920737 61920738 61938057 61938059 62001220 62001221 62001222 62001223 62037832 62038778 62038780 62086378 62086379 62086380 62086381 62086382 62086383 62086384 62086385 62086386 62086387 62086388 62086389 62086390 62086391 62086392 62086393 62086394 62086395 62086396 62086397 62086398 62086402 62086404 62086406 62142028 62142049 62142052 62194672 62194673 62194674 62194675 62194676 62204373 62204376 62204380 62204382 62204383 62204384 62204385 62204386 62224470 62224471 62224472 62224473 62224474 62224476 62224478 62224481 62224482 62224484 61721663 61729677 61763525 61878837 61934291 61934294 62001224 62001225 62038781 62081599 62081601 62081602 62081603 62081604 62081605 62081606 62081607 62081609 62081610 62081611 62081613 62081614 62081615 62081616 62142029 62142030 62142059 62142060 62142061 62197208 62197209 62197210 62197211 62197212 62204371 62204372 61621186 61915278 61915279 62081010 62081016 62081022 62081023 62081560 62081563 62081564 62081566 62081567 62081569 62228022 61789434 61804375 61826365 61851870 61900983 61950087 61950088 61968085 62008111 62137041 62244840 62262053 61621140 61676190 61677326 61677327 61800222 61800223 61800224 61817405 61826370 61826372 61826377 61826379 61851871 61897074 61897076 61897077 61897078 61900986 61900987 61900988 61900989 61904874 61904875 61904876 61904877 61940615 61940616 61940620 61964039 61964040 61964041 61964042 61987104 61987105 62008112 62008113 62093535 62093541 62134442 62134443 62134444 62165484 62189521 62189523 62189526 62262059 62262062 61597013 61621147 61621148 61664940 61676198 61676199 61676201 61676207 61676209 61676212 61676213 61789440 61789441 61789442 61804380 61804381 61804382 61821680 61821681 61826380 61826381 61826382 61826383 61826385 61839146 61839147 61851881 61851883 61851884 61851885 61851887 61851888 61876357 61876358 61876359 61876360 61876361 61898426 61898427 61898428 61898431 61904878 61904879 61904880 61904881 61908119 61908120 61908121 61908122 61937978 61937981 61937982 61937990 61937993 61938012 61949224 61949225 61949226 61950091 61950092 61950093 61987146 61987147 61987148 61987149 61988422 61988423 62008114 62008115 62008116 62008117 62008118 62038725 62038727 62093509 62093510 62093512 62093514 62093516 62093521 62093527 62109914 62111430 62111431 62118389 62118390 62118391 62118393 62118394 62118395 62118396 62189527 62189528 62189529 62189530 62189531 62253375 62253377 62253379 62262070 61597015 61597019 61652468 61677340 61677343 61677344 61677345 61677346 61693595 61693596 61763560 61763561 61763562 61763563 61789436 61789437 61789438 61789439 61804384 61804385 61804387 61836994 61836995 61836996 61836997 61836998 61843701 61843702 61843703 61843704 61843705 61855489 61855490 61855492 61855493 61855494 61855495 61855496 61855497 61855498 61855499 61865668 61865669 61865670 61865671 61865673 61865674 61865675 61865676 61865678 61865679 61881334 61881335 61881336 61881337 61881338 61881339 61881340 61881341 61881342 61912619 61912620 61912622 61912624 61912625 61920729 61920731 61920732 61920733 61920734 61920735 61920736 61952712 61952713 61952714 61979083 61979084 61979085 61979087 61979088 61979090 61983674 61983675 61983676 61983680 61983685 62001226 62001227 62001228 62001229 62001230 62001231 62031657 62031659 62031662 62033054 62033055 62033056 62038737 62038739 62093494 62093495 62093496 62093497 62093498 62093499 62093501 62093503 62093507 62118397 62118398 62118399 62118402 62118405 62118406 62118408 62118409 62181752 62181754 62189532 62189533 62189535 62189536 62244845 62244846 62244847 62244848 62244849 62244850 62253393 62253394 61677641 61677642 61677651 61709156 61709157 61763569 61763570 61763571 61763572 61763573 61763574 61763575 61763576 61763577 61804390 61804391 61821682 61821683 61826387 61826388 61826389 61826390 61839139 61839140 61839141 61843706 61843707 61851891 61851892 61851893 61851895 61868320 61868322 61868326 61868328 61868330 61868334 61868339 61868343 61868345 61868346 61868348 61868366 61868371 61868372 61893777 61893778 61893779 61893780 61893781 61893782 61893783 61900990 61900992 61900993 61900995 61900996 61900997 61925173 61925174 61925175 61925176 61925177 61952715 61952716 61952717 61954819 61954827 61954832 61954833 61954835 61968102 61968105 61968108 61982448 61982449 61983690 61983691 62005543 62005544 62005545 62005546 62005547 62038751 62038755 62093547 62093550 62093555 62093560 62093561 62093565 62093569 62093572 62093574 62093578 62144966 62144968 62144969 62144970 62181741 62181742 62189537 62189538 62189540 62189541 62253402 62253403 62253404 61564764 61578718 61597029 61621176 61665046 61677654 61677655 61677656 61677665 61677666 61693731 61821685 61821686 61826394 61826401 61826405 61826410 61851897 61851899 61851901 61871165 61871167 61871168 61871170 61871173 61871174 61871175 61871176 61871188 61904883 61904885 61904886 61904887 61925178 61925179 61960119 61960121 61960122 61960123 61988421 62005549 62005550 62005551 62031684 62031685 62093588 62093591 62093595 62093602 62093608 62137158 62137161 62137162 62165493 62181745 62181748 62224324 62224325 62224326 61564766 61804372 61804373 61804374 61817410 61826412 61826413 61826414 61851907 61858144 61858146 61858147 61858148 61858149 61858150 61858151 61925180 61925181 61964035 61964036 61964037 61964038 62033057 62033058 62093610 62093611 62093612 62137166 62137171 62181749 62181750 62244842 62244843 62244844 61584894 61821689 61830463 61830464 61830465 61830466 61872528 61872529 61900998 61900999 61925183 61925184 61952718 61952719 61952720 61988424 62008164 62056660 62056661 62137176 62171775 62176013 62189549 61789427 61789428 61789429 61821688 61830470 61851909 61872512 61872515 61912628 61912629 61952721 61952722 61952723 62165498 61809840 61817411 61866631 61901001 61912630 62033059 62253407 62326525 62326525N 61776805 61809841 61817413 62137190 61871512 61912633 61584905 61904888 61915248 61915249 61584893 61827245 62137720 61789432 61800204 61879922 61879923 61897081 61934223 61968086 61979076 62007789 62118452 62118454 62134902 62134904 62248047 61800214 61878890 61878892 61934230 62007784 62118386 62118387 62244851 62248048 61915250 61915260 62114113 61709146 61929355 62081574 62081580 62081581 62081584 62248045 61881375 62120989 62120990 62120991 62120992 62133208 62134898 62134899 61915265 62120985 62120986 62120987 62120988 62121159 62134901 61709162 61881379 62120980 62120982 61819836 62364108
• Recalling Firm/ Manufacturer: Zimmer Manufacturing B.V.; Turpeaux Industrial Park Rd 1 km 123.4; Mercedita PR 00715
• For Additional Information Contact: Consumer Relations Call Center; 800-447-5633
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Packaging
• Action: Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
• Quantity in Commerce: 1777
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HSB and Original Applicant = ZIMMER, INC.