—#98788

Product

REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.

FDA product code: GAB — Needle, Suturing, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part Number 906764, Lots 748580, 748730 and 932650.

Why it was recalled

The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.

Root cause (FDA determination)

Process control

Action the firm took

The firm, BIOMET, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated March 10, 2011 to all customers. The letter described the product, problem and actions to be taken. The letter noted that -Use of a non-sterile Curvtek Eye Needle may lead to patient infection, possibly requiring a revision procedure. The customers were instructed to immediately locate, discontinue use of the product , remove the product from circulation and return the product to Biomet; carefully follow the instructions on the enclosed FAX BACK RESPONSE FORM; complete and return the response form via fax to 574-372-1683 prior to return of product; use priority carrier for shipment, and please confirm receipt of this notice by calling 800-348-9500, extension 3755 or 3756. The firm also informed physicians that had previously utilized the device to monitor patients for infection and provide treatment as appropriate. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8am to 5pm.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.

Timeline

Recall initiated: 2011-03-10
Posted by FDA: 2011-04-06
Terminated: 2011-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.