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U.S. Department of Health and Human Services

Class 2 Device Recall Gomco Circumcision Clamps with separate ORing

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 Class 2 Device Recall Gomco Circumcision Clamps with separate ORingsee related information
Date Initiated by FirmOctober 28, 2016
Create DateJanuary 05, 2017
Recall Status1 Terminated 3 on January 30, 2018
Recall NumberZ-0947-2017
Recall Event ID 75937
Product Classification Clamp, circumcision - Product Code HFX
ProductGomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Code Information Material Code MG096R  (1.1 CM) MG097R  (1.3 CM) MG227 (1.45CM) MG228  (1.6CM) MG229  (2.1 CM) MG230  (2.6CM) 
FEI Number 2916714
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946
Manufacturer Reason
for Recall		Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
FDA Determined
Cause 2		Under Investigation by firm
ActionAesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.
Quantity in Commerce437 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
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