FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.
- Recall number
- Z-1309-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.
- Status
- Terminated
- Initiated
- 2006-06-02
- Posted
- 2006-08-02
- Terminated
- 2007-04-17
- Reason
- The packages are labeled sterile, but the product was not sterilized.
- Root cause
- Other
- Action
- Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
- Quantity
- 5
- Distribution
- Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.
- Lot, serial or model codes
- Lot 8379834.
- 510(k) numbers
- ["K932925"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 1828132
- Firm city
- Spencer
- 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