REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BE

FDA device recall Z-1903-2011 · posted 2011-04-06 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

GAB

Quantity affected

35

Distribution

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

Date initiated

2011-03-10

Date posted

2011-04-06

Date terminated

2011-07-27

Location

Warsaw, IN