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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-1101-2016
Recall Event ID 72900
510(K)Number K955473  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Product 3 consists of all products under product code JDI, and same usage:
Item no:781803800 12/14 UNIPOLAR FEMORAL HE
781804000 12/14 UNIPOLAR FEMORAL HE
781804100 12/14 UNIPOLAR FEMORAL HE
781804200 12/14 UNIPOLAR FEMORAL HE
781804300 12/14 UNIPOLAR FEMORAL HE
781804400 12/14 UNIPOLAR FEMORAL HE
781804500 12/14 UNIPOLAR FEMORAL HE
781804600 12/14 UNIPOLAR FEMORAL HE
781804700 12/14 UNIPOLAR FEMORAL HE
781804800 12/14 UNIPOLAR FEMORAL HE
781804900 12/14 UNIPOLAR FEMORAL HE
781805000 12/14 UNIPOLAR FEMORAL HE
781805100 12/14 UNIPOLAR FEMORAL HE
781805200 12/14 UNIPOLAR FEMORAL HE
781805300 12/14 UNIPOLAR FEMORAL HE
781805400 12/14 UNIPOLAR FEMORAL HE
781805500 12/14 UNIPOLAR FEMORAL HE
781806300 12/14 UNIPOLAR FEMORAL HE
781809900 12/14 UNIPOLAR FEMORAL HE
781809901 12/14 UNIPOLAR FEMORAL HE
781809902 12/14 UNIPOLAR FEMORAL HE

Product For use in total or hemi hip arthroplasty
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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 2,239
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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