FDA Medical Device Recalls (openFDA)
Bioplate Inc: Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
- Recall number
- Z-0043-2007
- Recalling firm
- Bioplate Inc
- Product
- Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
- Status
- Terminated
- Initiated
- 2006-09-12
- Posted
- 2006-10-19
- Terminated
- 2011-09-14
- Reason
- Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
- Root cause
- Other
- Action
- Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter. 100% of the consignees will be notified of the recall. Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.
- Quantity
- 36 units
- Distribution
- Nationwide to: CA, DC, GA, MI, OH, & PA
- Lot, serial or model codes
- Lot number: S29640905
- 510(k) numbers
- ["K051845"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 1000518793
- Firm city
- Los Angeles
- 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