FDA Medical Device Recalls (openFDA)
Kerr Corp: OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
- Recall number
- Z-1521-06
- Recalling firm
- Kerr Corp
- Product
- OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
- Status
- Terminated
- Initiated
- 2006-08-29
- Posted
- 2006-09-23
- Terminated
- 2012-08-03
- Reason
- Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.
- Root cause
- Other
- Action
- A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers. Periodic effectiveness checks will be conducted in order to follow up with non-responders.
- Quantity
- 247 Kits (50 unidose pouches/Kit)
- Distribution
- World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom
- Lot, serial or model codes
- Lot numbers: 448798, 449556 and 451706
- 510(k) numbers
- ["K014027","K991808"]
- PMA numbers
- not on file
- Product code
- KLE
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- 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