Z-1773-2010

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number...

Name: Z-1773-2010 Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number...
Creator: Boston Scientific Corporation
Published: 2010-05-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-05-06 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334 on 2010-05-06. The reason FDA records is "Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1773-2010
Status: Terminated
Initiated: 2010-05-06
Posted: 2010-06-04
Terminated: 2011-09-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334
Product code: FCL Forceps, Biopsy, Non-Electric
Reason for recall: Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.
Distribution: Nationwide; Panama.
Product codes and lots: Lots: 13361332, 13361334

Product code FCL

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)