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 Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

FDA Recall Z-2204-2010 · Posted 2010-08-10

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-04-20
Date Terminated2011-01-19
Product Quantity5

Reason for Recall

A knee implant labeled as left was opened and the package actually contained a right knee implant.

Firm Action

On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.

Root Cause

Process control

Distribution Pattern

1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan

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.

↑