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Terminated

Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.

FDA Recall Z-1309-06 · Posted 2006-08-02

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeJDR
Date Initiated2006-06-02
Date Terminated2007-04-17
Product Quantity5

Reason for Recall

The packages are labeled sterile, but the product was not sterilized.

Firm Action

Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.

Root Cause

Other

Distribution Pattern

Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932925BONE ANCHOR FOR SOFT TISSUE ATTACHMENTVesitec Medical, Inc. · 1994-04-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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