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Terminated

Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

FDA Recall Z-0496-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-10-22
Date Terminated2019-12-11
Product Quantity8 units

Reason for Recall

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

Firm Action

Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Root Cause

Labeling mix-ups

Distribution Pattern

AR, MO, MN, NJ, NY, OH, MN , NJ, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113550VANGUARD COMPLETE KNEE SYSTEMBiomet Manufacturing Corp · 2012-02-29K023546MAXIM ACCEL KNEE SYSTEMBiomet, Inc. · 2003-01-17

Official Source

View FDA Recall →

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

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