| | Class 2 Device Recall Gyrus ACMI |  |
| Date Initiated by Firm | February 19, 2007 |
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| Date Posted | March 13, 2007 |
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| Recall Status1 |
Terminated 3 on February 24, 2008 |
| Recall Number | Z-0614-2007 |
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| Recall Event ID |
37404 |
| 510(K)Number | K932293 |
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| Product Classification |
Forceps - Product Code KNS
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| Product | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901 |
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| Code Information |
Lot Nos.: 6258014, 6303028, 6306017, 6312602, 6314021, 6320034, 6326096, 6335040, 6342010, 6362025, 7004015, 7009015 |
Recalling Firm/
Manufacturer |
Gyrus ACMI Corporation
136 Turnpike Rd
Southborough MA 01772-2118
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Manufacturer Reason
for Recall | Product sterility may be compromised due to failure of the tray seal packaging |
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FDA Determined
Cause 2 | Packaging process control |
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| Action | Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product . |
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| Quantity in Commerce | 184 boxes (5 units/box) |
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| Distribution | Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain. |
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| Total Product Life Cycle | TPLC Device Report |
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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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| 510(K) Database | 510(K)s with Product Code = KNS
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