Recall Z-1588-2011 ยท HRX Arthroscope
Biomet, Inc.
Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE
| Date | Mar 7, 2011 (initiated Feb 10, 2011) |
| Status | Terminated |
| Reason | 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 | Process design |
| 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. |
| Quantity | 343 |
| Distribution | Distribution USA nationwide and to the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM Biomet Orthopedics, Inc., Jan 14, 2008 |