Z-1218-2017Class II

GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

Name: Z-1218-2017 GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Creator: Aesculap Implant Systems LLC
Published: 2017-01-09
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-01-09 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories on 2017-01-09. FDA classified it as Class II and gives the reason as "Generators may have a faulty component which could impact the proper functioning of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1218-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-09
Posted: 2017-02-16
Terminated: 2017-06-14
Recalling firm: Aesculap Inc
Product: GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Generators may have a faulty component which could impact the proper functioning of the device.
Root cause tag: manufacturing process
FDA root cause: 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).
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1218-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1218-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16

Product code GEI

K151858Class IICaiman Seal and Cut TechnologyAesculap, Inc. / cleared 2015-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)