FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
- Recall number
- Z-1218-2017
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
- Status
- Terminated
- Initiated
- 2017-01-09
- Posted
- 2017-02-16
- Terminated
- 2017-06-14
- Reason
- Generators may have a faulty component which could impact the proper functioning of the device.
- 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
- 24 generators
- Distribution
- USA (nationwide Distribution).
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K151858"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28