Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14, Rx, Sterile; 00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17, Rx, Sterile; 00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20, Rx, Sterile; 00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

FDA Recall Z-2032-2013 · Posted 2013-08-22

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2013-06-07
Date Terminated2014-12-15
Product Quantity192,355 all devices

Reason for Recall

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Firm Action

Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the country of Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑