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ConMed DetachaTip Multi-Use Laparoscopic Instrument -… recallZ-1433-06 · Conmed Corporation · initiated Mar 27, 2006

Terminated All recalls posted in August 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Conmed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1433-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 27, 2006
Posted by the FDA
Aug 24, 2006
Recalling firm
Conmed Corporation
Quantity
5205 units
Product code
GEI
FDA submissions
K924283
Distribution
Worldwide

Product description

ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

Code information (models, lots, serial numbers)

Product Code: 1-1008; all lot codes manufactured between 10/20/2003 and 2/16/2005. 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.

Other devices under the same FDA submission

1 device cleared under K924283 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 35949).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page