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U.S. Department of Health and Human Services

Class 2 Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE

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  Class 2 Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE see related information
Date Initiated by Firm March 10, 2011
Date Posted April 06, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-1903-2011
Recall Event ID 58241
Product Classification Needle, suturing, disposable - Product Code GAB
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.
Code Information Part Number 906764, Lots 748580, 748730 and 932650.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact Victor Rodgers
574-371-3755
Manufacturer Reason
for Recall		 The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 35
Distribution Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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