Z-1308-06

Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No...

Name: Z-1308-06 Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No...
Creator: Boston Scientific Corp
Published: 2006-06-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-06-02 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000) on 2006-06-02. The reason FDA records is "The packages are labeled sterile, but the product was not sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1308-06
Status: Terminated
Initiated: 2006-06-02
Posted: 2006-08-02
Terminated: 2007-04-17
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).
Product code: JDR Staple, Fixation, Bone
Reason for recall: The packages are labeled sterile, but the product was not sterilized.
Root cause tag: labeling and UDI
FDA 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 in commerce: 22 kits.
Distribution: Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.
Product codes and lots: Lots 8555778, 8552615 and 8718072.

Product code JDR

K932925Class IIBone Anchor for Soft Tissue AttachmentVesitec Medical, Inc. / cleared 1994-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)