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Terminated

AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

FDA Recall Z-0628-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-08-25
Date Terminated2018-08-09
Product Quantity11 devices

Reason for Recall

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Firm Action

Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to [email protected].

Root Cause

Process change control

Distribution Pattern

US Nationwide Distribution to IN, MO, NY, TX.

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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