FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2153-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-01-26
- Posted
- 2011-05-06
- Terminated
- 2013-06-21
- 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 (1.3cm) 100211 (1.1cm) and 100060409 (1.3cm) If you have any further questions, please call (703) 541-0196.
- Quantity
- 6100 clamps
- Distribution
- Class 2 Recall -- Nationwide Distribution.
- Lot, serial or model codes
- Lots: 100210 (1.3 cm), 100211 (1.1 cm), 100060409 (1.3 cm)
- 510(k) numbers
- ["K043533"]
- PMA numbers
- not on file
- Product code
- HFX
- Firm FEI
- 3001236105
- Firm city
- Lorton
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28