Z-2153-2011

Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the...

Name: Z-2153-2011 Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the...
Creator: Surgical Design Inc
Published: 2011-01-26
License: https://open.fda.gov/license/

Surgical Design Inc / initiated 2011-01-26 / Terminated / root cause: manufacturing process

FDA source

Surgical Design Inc began a recall of Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male... on 2011-01-26. The reason FDA records is "Medical device used in surgical procedure is defective and may break during use". 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-2153-2011
Status: Terminated
Initiated: 2011-01-26
Posted: 2011-05-06
Terminated: 2013-06-21
Recalling firm: Surgical Design Inc
Product: Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Product code: HFX Clamp, Circumcision
Reason for recall: Medical device used in surgical procedure is defective and may break during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Surgical Design, Inc. sent a Customer letter dated February 23, 2011, informing them of the affected product and providing instructions for its specific consignees. The instructions to the User is to please check your inventory to determine whether any Circumcision Clamps bought directly match those on your shelves. Please fill out the form and mail it to Surgical Design at the address on the form. If any clamps from the affected lots remain in your inventory, please ship them back to Surgical Design, noting the number being returned on the Reply form. These are the affected Lots. 100210 (1.3cm) 100211 (1.1cm) and 100060409 (1.3cm) If you have any further questions, please call (703) 541-0196.
Quantity in commerce: 6100 clamps
Distribution: Class 2 Recall -- Nationwide Distribution.
Product codes and lots: Lots: 100210 (1.3 cm), 100211 (1.1 cm), 100060409 (1.3 cm)

Product code HFX

K043533Class IISurgical Design Circumcision ClampSurgical Design, Inc. / cleared 2005-04-01

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)