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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-1147-2016
Recall Event ID 72900
510(K)Number K933785  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Product 49 consists of all product under product code: JWH and same usage:
Item no:
597206529 NEXGEN ALL-POLY PATELLA,
597206532 NEXGEN ALL-POLY PATELLA,
597206535 NEXGEN ALL-POLY PATELLA,
597206538 NEXGEN ALL-POLY PATELLA,
597206541 NEXGEN ALL-POLY PATELLA,
598801713 NEXGEN CEMENTED STEM EXT
598801813 NEXGEN CEMENTED STEM EXT
598801913 NEXGEN CEMENTED STEM EXT
598801610 NEXGEN FLUTED STEM EXT, 1
598801611 NEXGEN FLUTED STEM EXT, 1
598801612 NEXGEN FLUTED STEM EXT, 1
598801613 NEXGEN FLUTED STEM EXT, 1
598801614 NEXGEN FLUTED STEM EXT, 1
598801615 NEXGEN FLUTED STEM EXT, 1
598801616 NEXGEN FLUTED STEM EXT, 1
598801618 NEXGEN FLUTED STEM EXT, 1
598801619 NEXGEN FLUTED STEM EXT, 1
598801620 NEXGEN FLUTED STEM EXT, 2
598801622 NEXGEN FLUTED STEM EXT, 2
598801624 NEXGEN FLUTED STEM EXT, 2
597206126 NEXGEN MICRO ALL-POLY PAT
597206129 NEXGEN MICRO ALL-POLY PAT
597206132 NEXGEN MICRO ALL-POLY PAT
597206135 NEXGEN MICRO ALL-POLY PAT

for use in total knee 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 53338
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 = JWH and Original Applicant = ZIMMER, INC.
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