Recalls / —
—#47250
Product
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.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K924283
- Affected lot / code info
- 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.
Why it was recalled
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Conmed Corporation
- Address
- 525 French Rd, Utica, New York 13502-5945
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2006-03-27
- Posted by FDA
- 2006-08-24
- Terminated
- 2012-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #47250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.