| Date Initiated by Firm |
January 11, 2016 |
| Date Posted |
March 12, 2016 |
| Recall Status1 |
Terminated 3 on April 13, 2017 |
| Recall Number |
Z-1142-2016 |
| Recall Event ID |
72900 |
| 510(K)Number |
K142442
|
| Product Classification |
Screw, fixation, bone - Product Code HWC
|
| Product |
Product 44 consists of all product under product code: HWC and same usage:
Item no:
114607099 MAGMA-FX CANN SCREW 7.0MM
114604099 MAGNA FX CANN SCREW 7.0MM
114603000 MAGNA-FX CANN SCREW 7.0MM
114603500 MAGNA-FX CANN SCREW 7.0MM
114604000 MAGNA-FX CANN SCREW 7.0MM
114604032 MAGNA-FX CANN SCREW 7.0MM
114604500 MAGNA-FX CANN SCREW 7.0MM
114604532 MAGNA-FX CANN SCREW 7.0MM
114604599 MAGNA-FX CANN SCREW 7.0MM
114605000 MAGNA-FX CANN SCREW 7.0MM
114605032 MAGNA-FX CANN SCREW 7.0MM
114605099 MAGNA-FX CANN SCREW 7.0MM
114605500 MAGNA-FX CANN SCREW 7.0MM
114605532 MAGNA-FX CANN SCREW 7.0MM
114605599 MAGNA-FX CANN SCREW 7.0MM
114606000 MAGNA-FX CANN SCREW 7.0MM
114606032 MAGNA-FX CANN SCREW 7.0MM
114606099 MAGNA-FX CANN SCREW 7.0MM
114606500 MAGNA-FX CANN SCREW 7.0MM
114606532 MAGNA-FX CANN SCREW 7.0MM
114606599 MAGNA-FX CANN SCREW 7.0MM
114607000 MAGNA-FX CANN SCREW 7.0MM
114607032 MAGNA-FX CANN SCREW 7.0MM
114607500 MAGNA-FX CANN SCREW 7.0MM
114607532 MAGNA-FX CANN SCREW 7.0MM
114607599 MAGNA-FX CANN SCREW 7.0MM
114608000 MAGNA-FX CANN SCREW 7.0MM
114608032 MAGNA-FX CANN SCREW 7.0MM
114608099 MAGNA-FX CANN SCREW 7.0MM
114608500 MAGNA-FX CANN SCREW 7.0MM
114608532 MAGNA-FX CANN SCREW 7.0MM
114608599 MAGNA-FX CANN SCREW 7.0MM
114609000 MAGNA-FX CANN SCREW 7.0MM
114609032 MAGNA-FX CANN SCREW 7.0MM
114609099 MAGNA-FX CANN SCREW 7.0MM
114609500 MAGNA-FX CANN SCREW 7.0MM
114609532 MAGNA-FX CANN SCREW 7.0MM
114609599 MAGNA-FX CANN SCREW 7.0MM
114610000 MAGNA-FX CANN SCREW 7.0MM
114610032 MAGNA-FX CANN SCREW 7.0MM
114610099 MAGNA-FX CANN SCREW 7.0MM
114610500 MAGNA-FX CANN SCREW 7.0MM
114610532 MAGNA-FX CANN SCREW 7.0MM
114610599 MAGNA-FX CANN SCREW 7.0MM
114611000 MAGNA-FX CANN SCREW 7.0MM
114611032 MAGNA-FX CANN SCREW 7.0MM
114611099 MAGNA-FX CANN SCREW 7.0MM
114611500 MAGNA-FX CANN SCREW 7.0MM
114611532 MAGNA-FX CANN SCREW 7.0MM
114611599 MAGNA-FX CANN SCREW 7.0MM
114612000 MAGNA-FX CANN SCREW 7.0MM
114612032 MAGNA-FX CANN SCREW 7.0MM
114612500 MAGNA-FX CANN SCREW 7.0MM
114612599 MAGNA-FX CANN SCREW 7.0MM
114613000 MAGNA-FX CANN SCREW 7.0MM
114613099 MAGNA-FX CANN SCREW 7.0MM
511007020 MGII KNEE SLF-TAP BONE ST
511007025 MGII KNEE SLF-TAP BONE ST
511007030 MGII KNEE SLF-TAP BONE ST
511007035 MGII KNEE SLF-TAP BONE ST
511007040 MGII KNEE SLF-TAP BONE ST
511007045 MGII KNEE SLF-TAP BONE ST
114204012 MINI MAGNA-FX CANN SCREW
114204016 MINI MAGNA-FX CANN SCREW
114204020 MINI MAGNA-FX CANN SCREW
114204024 MINI MAGNA-FX CANN SCREW
114204028 MINI MAGNA-FX CANN SCREW
114204032 MINI MAGNA-FX CANN SCREW
114204036 MINI MAGNA-FX CANN SCREW
114204040 MINI MAGNA-FX CANN SCREW
114204044 MINI MAGNA-FX CANN SCREW
114204048 MINI MAGNA-FX CANN SCREW
114204055 MINI MAGNA-FX CANN SCREW
114204065 MINI MAGNA-FX CANN SCREW
114204124 MINI MAGNA-FX CANN SCREW
114204126 MINI MAGNA-FX CANN SCREW
114204128 MINI MAGNA-FX CANN SCREW
114204130 MINI MAGNA-FX CANN SCREW
114204132 MINI MAGNA-FX CANN SCREW
114204134 MINI MAGNA-FX CANN SCREW
114204136 MINI MAGNA-FX CANN SCREW
114204138 MINI MAGNA-FX CANN SCREW
114204140 MINI MAGNA-FX CANN SCREW
114204142 MINI MAGNA-FX CANN SCREW
114204144 MINI MAGNA-FX CANN SCREW
114204146 MINI MAGNA-FX CANN SCREW
114204148 MINI MAGNA-FX CANN SCREW
114204150 MINI MAGNA-FX CANN SCREW
114204155 MINI MAGNA-FX CANN SCREW
114204160 MINI MAGNA-FX CANN SCREW
114204165 MINI MAGNA-FX CANN SCREW
114204170 MINI MAGNA-FX CANN SCREW
114205012 MINI MAGNA-FX CANN SCREW
114205016 MINI MAGNA-FX CANN SCREW
114205020 MINI MAGNA-FX CANN SCREW
114205024 MINI MAGNA-FX CANN SCREW
114205028 MINI MAGNA-FX CANN SCREW
114205032 MINI MAGNA-FX CANN SCREW
114205036 MINI MAGNA-FX CANN SCREW
114205040 MINI MAGNA-FX CANN SCREW
114205044 MINI MAGNA-FX CANN SCREW
114205048 MINI MAGNA-FX CANN SCREW
114205055 MINI MAGNA-FX CANN SCREW
114205065 MINI MAGNA-FX CANN SCREW
114205124 MINI MAGNA-FX CANN SCREW
114205126 MINI MAGNA-FX CANN SCREW
114205128 MINI MAGNA-FX CANN SCREW |
| Code Information |
lot no.: 61740618 61740619 61931831 61920071 62221457 61825071 61926436 62036483 62221458 61758528 61820880 61878510 62098534 62221459 61851882 61986815 61825053 61851890 61926437 62094921 62181573 62221461 61878509 62098535 62181574 61758529 61828387 61851894 61915518 61979050 62065546 62065954 62160485 62221462 62253412 61878508 61979052 62181575 62253417 61930994 61812109 61812110 61857821 61898941 61898944 62065556 62065966 62160486 62225720 61830574 61926438 62112852 62253418 62181576 61758530 61798087 61831417 61851896 61920073 61920076 61979053 61986817 62191389 62260412 61627280 61758593 61851898 61920080 61979057 62098542 62191391 62260435 61740613 61620151 61740615 61758597 61814991 61851906 61851908 61857822 61920081 61964951 61964953 61979058 62098544 62191387 62225721 61825064 61851910 61918613 61964954 62036488 62120735 62181577 62260456 62160478 61627282 61740616 61758600 61825051 61825052 61851911 61851913 61915519 61979059 61979060 62094922 62094923 62122194 62181545 62181546 62210926 62210928 62265689 62265690 61678540 61758601 61851912 61926442 62036492 62112496 62204454 61678541 61758603 61758605 61798068 61825059 61835206 61844448 61844451 61851918 61898975 61898978 61964957 61964960 61979062 62065551 62065961 62120742 62144846 62204457 62204458 62204460 61835208 61920082 61979063 62094924 62120743 62253422 62141639 61740623 61740625 61758611 61820859 61825063 61830556 61844453 61844454 61851926 61857823 61915364 61915365 61915366 61964962 61964963 61986818 61986819 62065542 62065944 62098546 62112497 62112498 62112499 62160487 62181578 62204470 62204474 62204478 62204481 61758631 61825125 61851930 61964458 62031594 62144847 62225722 61812106 62141640 61740632 61752977 61810352 61825057 61830554 61835211 61851932 61851935 61851939 61878511 61898980 61915520 61964964 61964965 61986820 62026967 62094925 62101351 62101359 62122193 62140571 62140572 62204488 62204489 62204491 62204492 61664696 61812125 61812127 61812128 61920083 61986824 62101364 62160489 62210929 62144848 61740637 61805630 61805633 61812107 61812108 61851944 61851947 61878512 61898981 61926443 61979065 61979066 62026968 62094926 62094927 62112501 62122192 62155384 62191396 62210931 62210933 62210934 61664698 61758637 61844455 61915516 61986607 62098549 62122191 62210936 62260496 61915517 62112503 62140573 61664699 61740639 61740642 61812129 61812131 61851959 61898982 61926446 61964967 61986829 62098551 62122062 62122189 62204577 62204584 62260521 61627293 61844456 61918620 62026969 62120748 62210937 62260539 62160479 62253428 61620156 61758641 61798069 61844457 61878521 61920084 61964966 61993209 62101327 62181567 62210939 62260563 61758642 61798074 61878522 61964459 62026970 62221463 62204448 61830583 61878523 61964968 62026971 62181568 62253433 61758644 61798076 61964460 62181569 62140575 61678556 61844458 61926449 62031600 62210940 61920085 62120754 62253435 62134740 61788364 61798083 62101329 62253444 61862316 61986619 62210941 62112519 62140570 61758653 61798078 61964969 62221464 62101331 62260598 61788365 61861314 61851961 62140577 62204450 62260625 61820857 61862318 61895928 61895929 61905865 61905866 61905867 61905868 62140578 |
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 |
4335 |
| 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 = HWC and Original Applicant = ZIMMER, INC.
|
