Class 2 Device Recall Gyrus ACMI

• Date Initiated by Firm: February 19, 2007
• Date Posted: March 13, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0613-2007
• Recall Event ID: 37404
• 510(K)Number: K932293
• Product Classification: Forceps - Product Code KNS
• Product: Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
• Code Information: Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012
• Recalling Firm/ Manufacturer: Gyrus ACMI Corporation; 136 Turnpike Rd; Southborough MA 01772-2118
• Manufacturer Reason for Recall: Product sterility may be compromised due to failure of the tray seal packaging
• FDA Determined Cause: Packaging process control
• Action: Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
• Quantity in Commerce: 527 boxes (5 units/box)
• Distribution: Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
• 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 = KNS