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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus ACMI PKS Seal Open Forceps.

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  Class 2 Device Recall Gyrus ACMI PKS Seal Open Forceps. see related information
Date Initiated by Firm August 18, 2009
Date Posted January 14, 2010
Recall Status1 Terminated 3 on March 06, 2012
Recall Number Z-0635-2010
Recall Event ID 53890
510(K)Number K024286  
Product Classification Electrosurgical cutting and coagulation device and accessories. - Product Code GEI
Product Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
Code Information all lots
Recalling Firm/
Manufacturer		 Gyrus ACMI Corporation
136 Turnpike Rd
Southborough MA 01772-2118
For Additional Information Contact
508-804-2600
Manufacturer Reason
for Recall		 Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.
FDA Determined
Cause 2		 Environmental control
Action An Urgent Medical Device Recall letter, dated 08/15/09 was sent to customers notifying them of the issue. The letter identified affected product, asked that they cease further use, remove affected devices from stockrooms, contact Gyrus ACMI customer service for a return goods authorization and return product to Gyrus ACMI at no charge. A reply form is also asked to be returned to Gyrus ACMI via fax. Questions and requests for a Return Goods Authorization are directed to Gyrus ACMI customer service at 1-888-524-7266.
Quantity in Commerce 93,665 total (63,418 US, 30,247 OUS)
Distribution US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
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 = GEI and Original Applicant = GYRUS MEDICAL, INC.
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