—#97863

Product

Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K072879
Affected lot / code info: PART NUMBER 922140, LOT NUMBERS-337350, 381090, 381110, 337340, 751560, 751550, 707500, 707520, 707480, 073120, 073140

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Distribution USA nationwide and to the Netherlands

Timeline

Recall initiated: 2011-02-10
Posted by FDA: 2011-03-07
Terminated: 2013-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.