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U.S. Department of Health and Human Services

Class 2 Device Recall Natural Knee II Revision Femoral Stem, 125mm

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  Class 2 Device Recall Natural Knee II Revision Femoral Stem, 125mm see related information
Date Initiated by Firm October 02, 2014
Date Posted July 01, 2015
Recall Status1 Terminated 3 on July 01, 2015
Recall Number Z-1948-2015
Recall Event ID 71531
510(K)Number K973412  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Code Information item 6215-12-185 Lots: 7884165 7884736 7884737 7884738 7890330 11011448 11012660 60394169 60415420 60515793 60564530 60601129 60614014 60797044 60803056 60841848 60922655 60922656 60927853 60989112 61017152 61104192 61135872 61200531 61284571 61366919 61464308 61505310 61533025 61566733 61742151 61780361 61784264 61834192 61834778 61840307 61930376 61947884 61947885 62097910 62146925 62195165 62249431 62281270 62305675 62317987 62358643 62448678 62536901 62536902 62536903 62546527 62560372 62587577 62610989 62624715 62624716 62624717 62624718 62709664 62709665 62709667 62709670 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Call Center
800-348-2759
Manufacturer Reason
for Recall		 Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
FDA Determined
Cause 2		 Package design/selection
Action On 10/2/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. through 8 p.m. ET.
Quantity in Commerce 352
Distribution US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.
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 = SULZER ORTHOPEDICS, INC.
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