FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE
- Recall number
- Z-1588-2011
- Recalling firm
- Biomet, Inc.
- Product
- Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE
- Status
- Terminated
- Initiated
- 2011-02-10
- Posted
- 2011-03-07
- Terminated
- 2013-08-27
- 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
- Lot, serial or model codes
- PART NUMBER 922140, LOT NUMBERS-337350, 381090, 381110, 337340, 751560, 751550, 707500, 707520, 707480, 073120, 073140
- 510(k) numbers
- ["K072879"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28