Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
FDA device recall Z-1589-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 264
- Distribution
- Distribution USA nationwide and to the Netherlands
- Date initiated
- 2011-02-10
- Date posted
- 2011-03-07
- Date terminated
- 2013-08-27
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNERVUE DIAGNOSTIC SCOPE SYSTEM (K072879) | Biomet Orthopedics, Inc. | 2008-01-14 |