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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-1120-2016
Recall Event ID 72900
510(K)Number K030265  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Product 22 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

For use in total or hemi hip arthroplasty
Code Information lot no.: 61907682 62038367 62106797 62161479 62240743 62268577 62344683 62030932 62106796 62148557 62206538 62240742 62303507 62352823 
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 16
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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