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U.S. Department of Health and Human Services

Class 3 Device Recall Cannulated Screw Ballista Percutaneous Pedicle Screw System

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  Class 3 Device Recall Cannulated Screw Ballista Percutaneous Pedicle Screw System see related information
Date Initiated by Firm April 02, 2009
Date Posted September 22, 2009
Recall Status1 Terminated 3 on September 23, 2009
Recall Number Z-2300-2009
Recall Event ID 51730
510(K)Number K061441  
Product Classification Pedicle screw spinal system - Product Code HSB
Product Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM;
Biomet Spine, 100 Interpace Parkway, Parsippany, NJ 07054

The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
Code Information Item number 2000-3445; lot numbers 705610, 710680, 741900.
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact William Hennig
973-299-9300 Ext. 1557
Manufacturer Reason
for Recall		 Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
Quantity in Commerce 112
Distribution Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = EBI, L.P.
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