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ConMed Laparoscopic Instrument: Babcock Disposable Grasper… recallZ-0095-2007 · Conmed Corporation · initiated Oct 12, 2006

Terminated All recalls posted in October 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

The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.

Recall details

Recall number
Z-0095-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 12, 2006
Posted by the FDA
Oct 27, 2006
Recalling firm
Conmed Corporation
Quantity
287 units
Product code
GCJ
FDA submissions
K943327
Distribution
Worldwide

Product description

ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6047-001. --- 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)

REF/Product Code 60-6047-001, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]

Other devices under the same FDA submission

1 device cleared under K943327 — 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 36515).

Sources and updates

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