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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm January 11, 2016
Date Posted March 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1166-2016
Recall Event ID 72900
510(K)Number K913649  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Product 68 consists of all product under product code: JDI and same usage:
Item no:
787101360 VERSYS CEM/REV/CALCAR 13X
787101361 VERSYS CEM/REV/CALCAR 13X
787101362 VERSYS CEM/REV/CALCAR 13X
787101363 VERSYS CEM/REV/CALCAR 13X
787101560 VERSYS CEM/REV/CALCAR 15X
787101561 VERSYS CEM/REV/CALCAR 15X
787101562 VERSYS CEM/REV/CALCAR 15X
787101563 VERSYS CEM/REV/CALCAR 15X
787101760 VERSYS CEM/REV/CALCAR 17X
787101761 VERSYS CEM/REV/CALCAR 17X
787101761 VERSYS CEM/REV/CALCAR 17X

For use in total or hemi hip arthroplasty
Code Information lot no.: 61750613 61750614 61868570 61952541 62024610 62030924 62038337 62042578 62050967 62050968 62055953 62058544 62062916 62067900 62076933 62079992 62086045 62097029 62112166 62114833 62132264 62134027 62134028 62143844 62143845 62159824 62199401 62199402 62202245 62222764 62225719 62236534 62240268 62240781 62240783 62244343 62244344 62256020 62256021 62256022 62264272 62270718 62277491 62277507 62277508 62305949 62305950 62312493 62312494 62315892 62318764 62320156 62325567 62326096 62332923 62332924 62332925 62340037 62340038 61843322 61856105 61864096 61868571 62042579 62055955 62055956 62076934 62076936 62086043 62112165 62114834 62132263 62143842 62197213 62199403 62207226 62244341 62244342 62256025 62257216 62266494 62268559 62279449 62287353 62291944 62298295 62299092 62305947 62317922 62326097 62340039 62340040 62005387 62024613 62069014 62097031 62134029 62192539 62202246 62225718 62234467 62255228 62264273 62268560 62291945 62325568 62333495 61925004 62050965 62060670 62079989 62105186 62240782 62257142 62260131 62260132 62312495 62333989 61708135 62030925 62050969 62055958 62067899 62079993 62097032 62194662 62195516 62234471 62234473 62256023 62256024 62256026 62291946 62291947 62317132 62317134 62318765 62333493 62338822 62338823 62055957 62079990 62112164 62159826 62207227 62244345 62257141 62277509 62293488 62305948 62320159 62330766 62043457 62079987 62194661 62244346 62249022 62264274 62326098 370621 61964719 62005385 62058545 62105185 62266493 62317921 61846922 62062915 62143841 62240784 62270717 62317920 62326099 62340042 61658292 62244347 62347297 
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 1220
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 and Original Applicant = ZIMMER, INC.
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