FDA Medical Device Recalls (openFDA)
Kerr Corp: Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290
- Recall number
- Z-0686-06
- Recalling firm
- Kerr Corp
- Product
- Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290
- Status
- Terminated
- Initiated
- 2006-03-03
- Posted
- 2006-03-28
- Terminated
- 2012-03-07
- Reason
- The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Root cause
- Other
- Action
- A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. 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.
- Quantity
- 6898
- Distribution
- Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.
- Lot, serial or model codes
- Lot Numbers: 427936, 428569, & 428290
- 510(k) numbers
- ["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