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U.S. Department of Health and Human Services

Class 2 Device Recall Speedpass Suture Lariat

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  Class 2 Device Recall Speedpass Suture Lariat see related information
Date Initiated by Firm June 18, 2010
Date Posted August 16, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall Number Z-2230-2010
Recall Event ID 56193
Product Classification Manual Surgical Instrument for General Use - Product Code MDM
Product SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904012.

Used to pass suture through tissue.
Code Information Lot numbers: 863920 and 863930.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
574-371-3755
Manufacturer Reason
for Recall		 The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.
FDA Determined
Cause 2		 Component design/selection
Action The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.
Quantity in Commerce 301 units total
Distribution Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia 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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