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U.S. Department of Health and Human Services

Class 2 Device Recall HGPII Screws

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  Class 2 Device Recall HGPII Screws see related information
Date Initiated by Firm October 11, 2013
Date Posted February 20, 2014
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-1025-2014
Recall Event ID 66500
510(K)Number K840643  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product HGP II ACETABULAR CUP BON
Code Information 60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499 61830570 62081013 62130755 62204493 60358198 60456662 60676065 60740508 60793418 60847420 60906711 60970346 61018601 61089082 61114463 61197927 61265392 61336977 61405285 61445415 61504347 61560488 61612779 61717244 61770502 61830571 61953544 62017892 62081014 62126660 62161132 62194338 62286121 60096604 60191638 60231058 60310154 60403566 60541147 60614769 60652079 60713588 60771842 60809040 60906712 60965173 61013603 61077260 61120020 61191847 61197928 61288037 61336979 61405286 61445416 61504866 61548952 61612780 61649225 61738511 61770503 61830572 61902195 61902196 62017893 62048834 62090584 62204494 62286108 60134456 60196503 60254570 60310198 60400186 60604759 60642280 60687794 60749489 60793419 60838387 60914317 60965174 61018602 61070794 61114467 61180328 61191849 61226932 61296291 61362816 61378482 61405287 61458844 61504348 61548956 61612781 61649239 61687332 61738512 61770504 61801685 61830573 61902198 61902199 62061747 62104331 62130756 62194340 62211466 62315402 60307754 60358199 60537583 60745919 60817921 60884347 60932061 61013580 61077263 61135531 61197929 61283948 61354050 61445417 61458847 61573708 61612782 61649249 61738514 61770505 61830569 61906698 61948762 62104332 62130758 62227608 62308540 60391769 60537584 60614771 60732352 60780619 60838388 60906713 60965175 61013604 61056224 61120060 61180329 61226933 61283949 61336980 61405288 61445418 61479405 61504351 61573709 61623853 61674477 61717245 61760696 61770506 61830575 61902204 62017896 62074012 62104333 62143479 62227609 62308549 60354639 60400189 60503574 60535463 60604758 60616222 60642282 60687795 60756662 60796168 60821835 60875850 60909007 60970354 61035977 61089087 61120021 61180330 61202417 61255507 61296294 61378483 61445419 61458849 61504867 61573710 61614838 61649255 61674478 61717246 61760701 61770507 61770508 61902205 61906700 62061648 62061649 62126661 62194341 62227610 62308555 60503575 60621432 60642283 60745920 60821836 60897238 60970356 61056225 61120022 61197933 61331593 61612777 61672382 61770509 62017898 62124391 62204495 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging
Action Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
Quantity in Commerce 7,044,680 total
Distribution 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.
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 and Original Applicant = ZIMMER, INC.
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