Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the p
FDA device recall Z-2153-2011 · posted 2011-05-06 · Terminated
Recall details
- Recalling firm
- Surgical Design Inc
- Reason for recall
- Medical device used in surgical procedure is defective and may break during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- HFX
- Quantity affected
- 6100 clamps
- Distribution
- Class 2 Recall -- Nationwide Distribution.
- Date initiated
- 2011-01-26
- Date posted
- 2011-05-06
- Date terminated
- 2013-06-21
- Location
- Lorton, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL DESIGN CIRCUMCISION CLAMP (K043533) | Surgical Design, Inc. | 2005-04-01 |