| Class 2 Device Recall GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CRFLEX GENDER SOLUTIONS | |
Date Initiated by Firm | November 29, 2017 |
Create Date | March 14, 2018 |
Recall Status1 |
Terminated 3 on April 02, 2020 |
Recall Number | Z-1059-2018 |
Recall Event ID |
78706 |
510(K)Number | K060370 K071107 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | CR-FLEX GSF PRECOAT SZ C-L
CR-FLEX GSF PRECOAT SZ C-R
CR-FLEX GSF PRECOAT SZ D-L
CR-FLEX GSF PRECOAT SZ D-R
CR-FLEX GSF PRECOAT SZ E-L
CR-FLEX GSF PRECOAT SZ E-R
CR-FLEX GSF PRECOAT SZ F-L
CR-FLEX GSF PRECOAT SZ F-R
CR-FLEX GSF PRECOAT SZ G-L
CR-FLEX GSK PRECOAT SZ G-R
" These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. |
Code Information |
00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-013-06 62120693 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 00-5750-014-01 62170342 00-5750-014-01 62170343 00-5750-014-05 62121555 00-5750-014-05 62166655 00-5750-014-02 61791935 00-5750-014-02 61791936 00-5750-014-02 61813666 00-5750-014-02 11400111 00-5750-014-02 61843131 00-5750-014-02 61862167 00-5750-014-02 61870724 00-5750-014-02 61890017 00-5750-014-02 61905264 00-5750-014-02 61914484 00-5750-014-02 61951689 00-5750-014-02 61970681 00-5750-014-02 61978269 00-5750-014-02 61990915 00-5750-014-02 62011560 00-5750-014-02 62022989 00-5750-014-02 62059374 00-5750-014-02 62072514 00-5750-014-02 62088280 00-5750-014-02 62093271 00-5750-014-02 62132082 00-5750-014-02 62134707 00-5750-014-02 62159269 00-5750-014-02 62170344 00-5750-014-02 62170384 00-5750-014-02 62171084 00-5750-014-06 62121229 00-5750-014-06 62135959 00-5750-014-06 62170385 00-5750-015-01 61797750 00-5750-015-01 61804265 00-5750-015-01 61809715 00-5750-015-01 61810409 00-5750-015-01 61819936 00-5750-015-01 61820642 00-5750-015-01 61829061 00-5750-015-01 61834876 00-5750-015-01 61842352 00-5750-015-01 61847666 00-5750-015-01 61863943 00-5750-015-01 61870821 00-5750-015-01 61878293 00-5750-015-01 61889443 00-5750-015-01 61895335 00-5750-015-01 11400226 00-5750-015-01 61902970 00-5750-015-01 61905209 00-5750-015-01 61909358 00-5750-015-01 61908315 00-5750-015-01 61916173 00-5750-015-01 61916174 00-5750-015-01 61921446 00-5750-015-01 61931666 00-5750-015-01 61941604 00-5750-015-01 61952956 00-5750-015-01 61958754 00-5750-015-01 61963888 00-5750-015-01 61966239 00-5750-015-01 61966240 00-5750-015-01 61979149 00-5750-015-01 61986108 00-5750-015-01 61996141 00-5750-015-01 62002081 00-5750-015-01 62002082 00-5750-015-01 62011329 00-5750-015-01 62018053 00-5750-015-01 62018142 00-5750-015-01 62028178 00-5750-015-01 62029873 00-5750-015-01 62029875 00-5750-015-01 62035840 00-5750-015-01 62042331 00-5750-015-01 62049388 00-5750-015-01 62055039 00-5750-015-01 62060477 00-5750-015-01 62064338 00-5750-015-01 62086643 00-5750-015-01 62091506 00-5750-015-01 62091507 00-5750-015-01 62086644 00-5750-015-01 62106697 00-5750-015-01 62116013 00-5750-015-01 62121558 00-5750-015-01 62121556 00-5750-015-01 62132523 00-5750-015-01 62132525 00-5750-015-01 62140119 00-5750-015-01 62148243 00-5750-015-01 62152391 00-5750-015-01 62155453 00-5750-015-01 62170954 00-5750-015-01 62170955 00-5750-015-01 62170956 00-5750-015-01 62170957 00-5750-015-01 62170958 00-5750-015-01 62172733 00-5750-015-01 62172742 00-5750-015-01 62172749 00-5750-015-01 62172737 00-5750-015-01 62172750 00-5750-015-05 61829059 00-5750-015-05 61979151 00-5750-015-05 62003579 00-5750-015-05 62075016 00-5750-015-05 62122660 00-5750-015-05 62133157 00-5750-015-05 62170401 00-5750-015-02 61794716 00-5750-015-02 61810412 00-5750-015-02 61811776 00-5750-015-02 61820645 00-5750-015-02 61824008 00-5750-015-02 61834877 00-5750-015-02 61838758 00-5750-015-02 61847670 00-5750-015-02 61862132 00-5750-015-02 61872331 00-5750-015-02 61876301 00-5750-015-02 61879242 00-5750-015-02 61885147 00-5750-015-02 61886280 00-5750-015-02 61890706 00-5750-015-02 61890043 00-5750-015-02 61904206 00-5750-015-02 61910227 00-5750-015-02 61910229 00-5750-015-02 61910889 00-5750-015-02 61918992 00-5750-015-02 61923590 00-5750-015-02 61936794 00-5750-015-02 61950709 00-5750-015-02 61950710 00-5750-015-02 61960710 00-5750-015-02 61964117 00-5750-015-02 61970682 00-5750-015-02 61973267 00-5750-015-02 61986430 00-5750-015-02 61986739 00-5750-015-02 61996356 00-5750-015-02 61996357 00-5750-015-02 62011576 00-5750-015-02 62011577 00-5750-015-02 62011578 00-5750-015-02 62011579 00-5750-015-02 62022109 00-5750-015-02 62020823 00-5750-015-02 62028437 00-5750-015-02 62033069 00-5750-015-02 62036622 00-5750-015-02 62043322 00-5750-015-02 62050766 00-5750-015-02 62060528 00-5750-015-02 62071255 00-5750-015-02 62075660 00-5750-015-02 62079865 00-5750-015-02 62087941 00-5750-015-02 62092277 00-5750-015-02 62094385 00-5750-015-02 62106698 00-5750-015-02 62107126 00-5750-015-02 62117325 00-5750-015-02 62121774 00-5750-015-02 62132865 00-5750-015-02 62132878 00-5750-015-02 62141732 00-5750-015-02 62141927 00-5750-015-02 62147818 00-5750-015-02 62152394 00-5750-015-02 62156825 00-5750-015-02 62166658 00-5750-015-02 62166748 00-5750-015-02 62171101 00-5750-015-02 62171102 00-5750-015-02 62171757 00-5750-015-02 62171762 00-5750-015-02 62171764 00-5750-015-02 62173170 00-5750-015-06 61797739 00-5750-015-06 61830366 00-5750-015-06 62003582 00-5750-015-06 62091562 00-5750-015-06 62122538 00-5750-015-06 62141936 00-5750-016-01 61794718 00-5750-016-01 61796369 00-5750-016-01 61804735 00-5750-016-01 61823887 00-5750-016-01 61834861 00-5750-016-01 61843134 00-5750-016-01 61879330 00-5750-016-01 61886333 00-5750-016-01 61890709 00-5750-016-01 61905190 00-5750-016-01 61905191 00-5750-016-01 61914487 00-5750-016-01 61929422 00-5750-016-01 61936004 00-5750-016-01 61946957 00-5750-016-01 61955579 00-5750-016-01 61962742 00-5750-016-01 61962744 00-5750-016-01 61976418 00-5750-016-01 61982466 00-5750-016-01 61996959 00-5750-016-01 62005925 00-5750-016-01 62007016 00-5750-016-01 62013511 00-5750-016-01 62022325 00-5750-016-01 62022324 00-5750-016-01 62034567 00-5750-016-01 62044626 00-5750-016-01 62063739 00-5750-016-01 62072219 00-5750-016-01 62080345 00-5750-016-01 62092539 00-5750-016-01 62093019 00-5750-016-01 62112670 00-5750-016-01 62119497 00-5750-016-01 62125812 00-5750-016-01 62137994 00-5750-016-01 62144301 00-5750-016-01 62152969 00-5750-016-01 62155068 00-5750-016-01 62171793 00-5750-016-05 61836353 00-5750-016-05 61970691 00-5750-016-05 11006472 00-5750-016-05 62093021 00-5750-016-05 62100379 00-5750-016-05 62126817 00-5750-016-02 61796371 00-5750-016-02 61798627 00-5750-016-02 61809722 00-5750-016-02 61819934 00-5750-016-02 61823891 00-5750-016-02 61823892 00-5750-016-02 61829840 00-5750-016-02 61844041 00-5750-016-02 61846258 00-5750-016-02 61867611 00-5750-016-02 61876284 00-5750-016-02 11400202 00-5750-016-02 61888046 00-5750-016-02 61893643 00-5750-016-02 61900478 00-5750-016-02 61905269 00-5750-016-02 61905271 00-5750-016-02 61914490 00-5750-016-02 61922259 00-5750-016-02 61936008 00-5750-016-02 61936677 00-5750-016-02 61946960 00-5750-016-02 61959246 00-5750-016-02 61959248 00-5750-016-02 11400318 00-5750-016-02 61968824 00-5750-016-02 61968857 00-5750-016-02 61976430 00-5750-016-02 61988466 00-5750-016-02 61989668 00-5750-016-02 61997351 00-5750-016-02 62005963 00-5750-016-02 62014079 00-5750-016-02 62014080 00-5750-016-02 62022326 00-5750-016-02 62022327 00-5750-016-02 62038034 00-5750-016-02 62046244 00-5750-016-02 62064361 00-5750-016-02 62073119 00-5750-016-02 62080827 00-5750-016-02 62088862 00-5750-016-02 62094391 00-5750-016-02 62106555 00-5750-016-02 62112673 00-5750-016-02 62130983 00-5750-016-02 62138093 00-5750-016-02 62146939 00-5750-016-02 62154050 00-5750-016-02 62163077 00-5750-016-02 62171794 00-5750-016-06 61843136 00-5750-016-06 61982989 00-5750-016-06 62007752 00-5750-016-06 62094390 00-5750-016-06 62138249 00-5750-017-01 61830532 00-5750-017-01 61870826 00-5750-017-01 61889195 00-5750-017-01 11400212 00-5750-017-01 11400228 00-5750-017-01 61943192 00-5750-017-01 61970695 00-5750-017-01 61977555 00-5750-017-01 62003098 00-5750-017-01 62036516 00-5750-017-01 62075677 00-5750-017-01 62134276 00-5750-017-01 62164340 00-5750-017-01 62172421 00-5750-017-05 62134278 00-5750-017-02 61830533 00-5750-017-02 61870831 00-5750-017-02 61890024 00-5750-017-02 61904207 00-5750-017-02 61906387 00-5750-017-02 61926131 00-5750-017-02 61931674 00-5750-017-02 61958023 00-5750-017-02 61963893 00-5750-017-02 61984229 00-5750-017-02 62003103 00-5750-017-02 62036517 00-5750-017-02 62081907 00-5750-017-02 62091452 00-5750-017-02 62146658 00-5750-017-02 62172422 00-5750-017-06 62134277 00-5750-017-06 62173183 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Kevin W. Escapule 574-372-4487 |
Manufacturer Reason for Recall | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
FDA Determined Cause 2 | Packaging |
Action | A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag.
A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additi |
Quantity in Commerce | 13,227 in total |
Distribution | Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE. |
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 = JWH
|
|
|
|