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FDA Medical Device Recalls (openFDA)

Conmed Corporation: ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

Recall number
Z-1434-06
Recalling firm
Conmed Corporation
Product
ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Status
Terminated
Initiated
2006-03-27
Posted
2006-08-24
Terminated
2012-04-27
Reason
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
Root cause
Other
Action
On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.
Quantity
3496 units
Distribution
Worldwide
Lot, serial or model codes
Product Code: 1-1028; all lot codes manufactured between 10/06/2003 and 2/14/2005. Each lot code is found on the package labeling of unopened units and is also embossed on the grey hub of the device. For 5 digit lot codes: the 1st digit represents the year (4 represents 2004), the 2nd & 3rd digits represent the month (09 for September), and the 4th & 5th digits for the day of the month. For 7 digit lot codes: the 1st two digits represent the year, the 3rd & 4th represent the month, the 5th & 6th represent the day of the month, and the 7th digit represents the manufacturing shift code.
510(k) numbers
["K924283"]
PMA numbers
not on file
Product code
GEI
Firm FEI
3001451571
Firm city
Utica
Firm state
NY
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

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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

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