Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
FDA Recall Z-1948-2015 · Posted 2015-07-01
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-10-02
Date Terminated2015-07-01
Product Quantity352
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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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