Z-0257-06

TLC Self -Retaining Retractor System-Single

Name: Z-0257-06 TLC Self -Retaining Retractor System-Single
Creator: Boston Scientific Corporation
Published: 2005-10-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-10-25 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of TLC Self -Retaining Retractor System-Single Product Code: 820-175 on 2005-10-25. The reason FDA records is "Sterility of device compromised due to breach in packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0257-06
Status: Terminated
Initiated: 2005-10-25
Posted: 2005-12-01
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: TLC Self -Retaining Retractor System-Single Product Code: 820-175
Product code: GAD Retractor
Reason for recall: Sterility of device compromised due to breach in packaging
Root cause tag: packaging
FDA root cause: Other
Action: Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
Quantity in commerce: 5185
Distribution: Nationwide
Product codes and lots: All lot codes

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)