FDA Medical Device Recalls (openFDA)
Gyrus ACMI Corporation: Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
- Recall number
- Z-0613-2007
- Recalling firm
- Gyrus ACMI Corporation
- Product
- Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
- Status
- Terminated
- Initiated
- 2007-02-19
- Posted
- 2007-03-13
- Terminated
- 2008-02-24
- Reason
- Product sterility may be compromised due to failure of the tray seal packaging
- Root 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
- 527 boxes (5 units/box)
- Distribution
- Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
- Lot, serial or model codes
- Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012
- 510(k) numbers
- ["K932293"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 3003790304
- Firm city
- Southborough
- Firm state
- MA
- 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