| Class 2 Device Recall Zimmer | |
Date Initiated by Firm | January 11, 2016 |
Date Posted | March 12, 2016 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number | Z-1119-2016 |
Recall Event ID |
72900 |
510(K)Number | K960658 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
Product | Product 21 consists of all product under product code: JDI and same usage:
Item no:
811400218 CPT 12/14 COCR REVISION S
811400318 CPT 12/14 COCR REVISION S
811400420 CPT 12/14 COCR REVISION S
811400423 CPT 12/14 COCR REVISION S
811400426 CPT 12/14 COCR REVISION S
811400010 CPT 12/14 COCR SIZE 0 EXT
811400000 CPT 12/14 COCR SIZE 0 STD
811400110 CPT 12/14 COCR SIZE 1 EXT
811400100 CPT 12/14 COCR SIZE 1 STD
811400210 CPT 12/14 COCR SIZE 2 EXT
811400200 CPT 12/14 COCR SIZE 2 STD
811400230 CPT 12/14 COCR SIZE 2 XEX
811400310 CPT 12/14 COCR SIZE 3 EXT
811400300 CPT 12/14 COCR SIZE 3 STD
811400330 CPT 12/14 COCR SIZE 3 XEX
811400410 CPT 12/14 COCR SIZE 4 EXT
811400400 CPT 12/14 COCR SIZE 4 STD
811400430 CPT 12/14 COCR SIZE 4 XEX
811400510 CPT 12/14 COCR SIZE 5 EXT
811400500 CPT 12/14 COCR SIZE 5 STD
811400530 CPT 12/14 COCR SIZE 5 XEX
Product Usage:
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |
Code Information |
lot no.: 61955193 61955194 61964624 61982550 62046482 62065282 62261923 62262772 62295082 62249027 62330762 62036886 62176426 62262773 61907680 62030928 62240741 62298284 62030929 61907674 61964631 61969290 61969291 62018466 62018468 62055978 62055980 62076923 62076924 62082567 62082568 62106792 62128913 62131432 62143850 62159845 62159846 62167370 62178690 62178691 62190353 62203977 62204524 62227026 62227027 62227029 62238072 62240247 62240730 62257224 62261914 62262774 62276442 62284459 62288119 62291920 62296540 62307970 62312487 62324098 62333959 62338563 62340055 62360134 62360140 61668394 61679041 61955610 61957414 61964634 61969286 61978765 61986788 61986790 62022714 62036889 62038366 62046483 62065284 62069521 62069522 62069524 62097046 62097047 62106790 62106791 62114854 62122106 62122107 62127729 62127730 62134924 62137237 62143848 62161474 62161475 62161476 62166255 62172022 62172025 62188287 62188306 62193415 62199384 62211968 62211969 62227033 62227034 62234448 62240728 62240729 62251948 62255221 62256007 62262770 62268570 62278680 62278681 62278682 62284458 62288118 62311635 62317908 62320170 62333489 62333490 62333491 62340051 62340052 62340053 62343732 62346560 62358887 62358889 62360121 62362779 61114608 61817973 61840599 61840601 61841631 61895489 61911441 61947699 61952551 61952552 61996733 62010642 62022717 62022718 62024620 62033222 62033223 62036884 62042582 62050975 62050976 62050977 62091839 62091840 62097049 62097050 62100682 62100683 62100684 62105194 62113215 62113216 62114845 62114846 62114847 62131429 62131430 62131431 62146099 62146101 62148559 62154544 62156184 62156185 62156186 62156187 62159840 62159843 62159844 62160581 62190351 62190352 62199387 62202244 62204526 62208749 62211974 62211975 62216681 62216682 62216683 62221870 62221871 62222756 62222757 62240243 62240735 62240736 62240737 62240738 62255224 62256009 62256010 62264279 62277489 62278683 62282929 62284461 62284472 62284473 62288123 62291921 62291924 62298275 62298276 62298277 62309267 62309268 62310416 62312484 62312486 62314706 62314707 62332911 62332912 62332913 62333425 62333426 62333964 62345379 62345380 62345381 62333426N 61679891 61813928 61885891 61885893 61891286 61895488 61918001 61918002 61918003 61957408 61978769 61983693 62014202 62033224 62042586 62042587 62065280 62065281 62069525 62069526 62069527 62069528 62075357 62086048 62086049 62086050 62086051 62091837 62091838 62114855 62114856 62114857 62118989 62118990 62122110 62127732 62131427 62131428 62133323 62133324 62134925 62136697 62136698 62136699 62137236 62140338 62140339 62140340 62151814 62151816 62154545 62156188 62160580 62166251 62166252 62166253 62167367 62167368 62167369 62171399 62171401 62172030 62172038 62176419 62178694 62190354 62199385 62202243 62204525 62206544 62208747 62208748 62211970 62211971 62221868 62221869 62222755 62227036 62227037 62234449 62234451 62238073 62240245 62240731 62240732 62240733 62240734 62251949 62251950 62255222 62256005 62256006 62262775 62264278 62268571 62275086 62276443 62277488 62281828 62282927 62282928 62284460 62284470 62284471 62288122 62303494 62310418 62310420 62310530 62311632 62311633 62317906 62320166 62320167 62325576 62328982 62328983 62328984 62328985 62333961 62339626 62339627 62339628 62340048 62340049 62340050 62345375 62345376 62345377 62349759 62358883 61882606 61955189 62003974 62036885 62075353 62075354 62076929 62076930 62086053 62086054 62106793 62106794 62114852 62114853 62118987 62127731 62136700 62136701 62136702 62137238 62151817 62151818 62161477 62161478 62167371 62171405 62176420 62180350 62180352
62180353 62180354 62180355 62180356 62193413 62208751 62210424 62223788 62223789 62233549 62234453 62249024 62249025 62250377 62250378 62257221 62257223 62261916 62261917 62291765 62291766 62291919 62296542 62296543 62296545 62296546 62298281 62298282 62303496 62305938 62312483 62317911 62324099 62328988 62328989 62337017 62337018 62338818 62338819 62338820 61882605 61952548 61969287 61987755 62010647 62036887 62036888 62050978 62075351 62075352 62086058 62086059 62086061 62086062 62086070 62086071 62086072 62118991 62125307 62125308 62125309 62133325 62133326 62140341 62140342 62140343 62143849 62145004 62154546 62156182 62156183 62160582 62171402 62171403 62183145 62183146 62188285 62188286 62199389 62221006 62222758 62234452 62240246 62240744 62240745 62250379 62256011 62264280 62268572 62273048 62273049 62275085 62276441 62277490 62278684 62284463 62291922 62298278 62298279 62303495 62317907 62320168 62320169 62326104 62326105 62327662 62327663 62330760 62333960 62340054 62344682 61957406 61964628 62006550 62006551 62030927 62097053 62128918 62140344 62166254 62176424 62203978 62222754 62223790 62255225 62268573 62281830 62296552 62340056 62360174 62362791 62362792 61914810 61947702 62006554 62010645 62050979 62100685 62105195 62114850 62114851 62148561 62151821 62151822 62183141 62183142 62193414 62221004 62234455 62240739 62249028 62255226 62256012 62268575 62278685 62284465 62303506 62307976 62312485 62317909 62325624 62343728 62343729 62358886 61884449 61957403 62003978 62042583 62060676 62075355 62075356 62086055 62113217 62114848 62114849 62118986 62140345 62143854 62148558 62151824 62151826 62188284 62210425 62238082 62249026 62251947 62251951 62268574 62273050 62282930 62291923 62309266 62315885 62317136 62328713 62330758 62346562 62360154 62360160 62050980 62146102 62183143 62183144 62238075 62273051 62296565 62354636 370132 61884451 61999775 62062918 62106795 62118985 62176425 62238077 62238081 62278686 62325625 62338564 62362793 62362794 61925024 62001328 62086057 62105193 62114844 62148560 62240740 62268576 62296566 62330759 62362796 62118988 62193416 62210429 62218112 62288121 62055985 62097055 62125306 62145003 62315886 62347011 62146103 62315884 62362781 62145005 62282926 |
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 2 | 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 | 1209 |
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 = JDI
|
|
|
|