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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun AM Aesculap

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 Class 2 Device Recall B. Braun AM Aesculapsee related information
Date Initiated by FirmNovember 30, 2015
Create DateMarch 03, 2016
Recall Status1 Terminated 3 on October 13, 2016
Recall NumberZ-1043-2016
Recall Event ID 72853
510(K)NumberK083772 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductColumbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Code Information All codes
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall		Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
FDA Determined
Cause 2		Packaging change control
ActionAesculap sent an Urgent Medical Device Correction letter to Distributors and Sales Rep. The letter identified the affected product, problem and actions to be taken. Customers were notified to add the over label to product packaging. Telephone conferences with Distributors and Sales Rep reiterated need for representative to inform Surgical Handler of the label when providing product for review. Customers were instructed to complete the attached Product Correction Acknowledgement Form and return to Aesculap Quality Assurance department by faxing the form to 610-791-6882 or e-mail to val.strawn@aesculap.com, two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
Quantity in Commerce1232
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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