Recall Z-2153-2011 ยท HFX Clamp, Circumcision
Surgical Design Inc
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.
| Date | May 6, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | Medical device used in surgical procedure is defective and may break during use. |
| 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 |
| Quantity | 6100 clamps |
| Distribution | Class 2 Recall -- Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043533 | SURGICAL DESIGN CIRCUMCISION CLAMP Surgical Design, Inc., Apr 1, 2005 |