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

Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581

FDA Recall Z-0123-2008 · Posted 2007-12-05

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-08-31
Date Terminated2008-06-04
Product Quantity16

Reason for Recall

Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

Firm Action

Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.

Root Cause

Packaging process control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023546MAXIM 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.

↑