Date Initiated by Firm | January 09, 2017 |
Date Posted | February 16, 2017 |
Recall Status1 |
Terminated 3 on June 14, 2017 |
Recall Number | Z-1218-2017 |
Recall Event ID |
76210 |
510(K)Number | K151858 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
Product | GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories |
Code Information |
Serial # 1229 1897 1898 1900 1909 1911 1929 1930 1932 1934 1938 1993 1997 1998 1999 2000 2029 2030 2031 2032 2037 2038 2039 2040 2041 2042 2045 2046 2047 2048 2049 2050 2051 2052 2168 |
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 | Generators may have a faulty component which could impact the proper functioning of the device. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Aesculap mailed an Urgent Medical Device Recall Notification letter dated January 9, 2017, to all affected customers. The notification letter advised customers to discontinue use and quarantine the affected unit if found. Customers were asked to complete the enclosed Acknowledgement form, list the serial number in their possession and return via fax at the number that was provided in the notification. For further questions, please call (800) 258-1946. |
Quantity in Commerce | 24 generators |
Distribution | USA (nationwide Distribution). |
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 = GEI
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