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.
FDA Recall Z-2153-2011 · Posted 2011-05-06
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Recalling FirmSurgical Design Inc
Recall StatusTerminated
Product CodeHFX
Date Initiated2011-01-26
Date Terminated2013-06-21
Product Quantity6100 clamps
Reason for Recall
Medical device used in surgical procedure is defective and may break during use.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Class 2 Recall -- Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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