Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.
FDA device recall Z-1309-06 · posted 2006-08-02 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The packages are labeled sterile, but the product was not sterilized.
- Action taken
- Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDR
- Quantity affected
- 5
- Distribution
- Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.
- Date initiated
- 2006-06-02
- Date posted
- 2006-08-02
- Date terminated
- 2007-04-17
- Location
- Spencer, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BONE ANCHOR FOR SOFT TISSUE ATTACHMENT (K932925) | Vesitec Medical, Inc. | 1994-04-26 |