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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 Zimmersee related information
Date Initiated by FirmJanuary 11, 2016
Date PostedMarch 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall NumberZ-1124-2016
Recall Event ID 72900
510(K)NumberK892800 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductProduct 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: For use in total or hemi hip arthroplasty
Code Information lot no.: 61555543 61597965 61670825 62079145 62079148 62124066 62135039 62185960 62203621 62221041 62221043 62221044 62267947 62267949 62267950 62268526 62277492 62277493 62278701 62278702 62278703 62340123 62397828 62397831 62267950N 62278701N 62278702N 62278703N 61597959 61653581 62218170 62265345 62277494 62294359 62218170N 62277494N 62294359N 61292730N 62122127 62267951 62267952 62278704 62267952N 62278704N 62181482 62304835 62304835N 62203622 62203622N 62289044 62391711 62289044N 62391711V 61854615 61977887 62135046 62162460 62267946 62268527 62340121 62268527N 62289054 62289083 62304837 62289054N 62289083N 62304837N 
Recalling Firm/
Manufacturer
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
For Additional Information ContactConsumer 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
ActionZimmer 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 Commerce0
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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