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 INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE

FDA Recall Z-1589-2011 · Posted 2011-03-07

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2011-02-10
Date Terminated2013-08-27
Product Quantity264

Reason for Recall

The cannula could not be connected to the scope and scopes disengage during use. The outer hub of Innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the Innervue hand piece. This condition may prevent the Innervue scope from being securely attached to the Innervue hand piece.

Firm Action

On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.

Root Cause

Process design

Distribution Pattern

Distribution USA nationwide and to the Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072879INNERVUE DIAGNOSTIC SCOPE SYSTEMBiomet Orthopedics, Inc. · 2008-01-14

Official Source

View FDA Recall →

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

↑