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U.S. Department of Health and Human Services

Class 2 Device Recall Circumcision Clamp, models 1.1cm and 1.3cm

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  Class 2 Device Recall Circumcision Clamp, models 1.1cm and 1.3cm see related information
Date Initiated by Firm January 26, 2011
Date Posted May 06, 2011
Recall Status1 Terminated 3 on June 21, 2013
Recall Number Z-2153-2011
Recall Event ID 58318
510(K)Number K043533  
Product Classification Circumcision Clamp - Product Code HFX
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.
Code Information Lots: 100210 (1.3 cm),  100211 (1.1 cm), 100060409 (1.3 cm) 
Recalling Firm/
Manufacturer		 Surgical Design Inc
7351 Lockport Pl Ste D
Lorton VA 22079-1571
For Additional Information Contact Ghalib Sethi
703-541-0196
Manufacturer Reason
for Recall		 Medical device used in surgical procedure is defective and may break during use.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HFX and Original Applicant = SURGICAL DESIGN, INC.
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