Class 2 Device Recall Juggerknot Soft Anchors

• Date Initiated by Firm: July 21, 2011
• Date Posted: August 31, 2011
• Recall Status: Terminated on April 26, 2013
• Recall Number: Z-3109-2011
• Recall Event ID: 59366
• 510(K)Number: K110145
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. ; ; Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
• Code Information: Lot #: M050020, Ml02470, M205970, M206170, M335840, M451670, M554290, M592790, M906510, M050030, M102480, M205980, M206180, M335860, M451680, M554300, M596210, M906540, M050040, M102490, M205990, M206200, M335870, M451690, M554310, M666350, M906550, M050050, M102500, M206000, M213400, M336170, M451700, M555140, M666360, M974690, M050060, M102510, M206010, M213410, M350540, M475050, M571420, M725330, M974720, M050070, M102520, M206030, M213420, M350550, M479960, M571560, M725340, M050080, M102530, M206060, M248050, M350560, M506760, M571570, M727850, M051940, M102540, M206070, M248060, M350570, M513940, M571580, M762160, M051950, M185150, M206080, M248070, M351000, M537410, M571600, M802400, M051960, M185160, M206090, M248080, M354670, M554260, M571730, M802410, M051970, M205940, M206140, M248090, M451650, M554270, M571760, M802420, M072920, M205960, M206150, M248100, M451660, M554280, M571800, and M860160
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Victor Rodgers; 574-371-3755
• Manufacturer Reason for Recall: The device packaging was punctured by the device, resulting in loss of implant sterility.
• FDA Determined Cause: Package design/selection
• Action: Biomet Sports Medicine notified distributor accounts by telephone on July 08, 2011 with instructions to quarantine all lots of the recalled product. Urgent Medical Device Recall Notice letters dated July 21, 2011 were sent to all affected customers. The letter identified the recalled product, problem, and actions to be taken. The customers were instructed to immediately locate and discontinue use of the recalled product. The distributors are advised to communicate this notice to their customers if the recalled products were further distributed. The letter also states that distributors are responsible for the return of the recalled product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Customers were instructed to provide phone confirmation at 800-348-9500, extension 3755 or 3756, when the recall notice is received. Further questions should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8 AM to 5 PM.
• Quantity in Commerce: 4925
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.
• 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 = MBI and Original Applicant = BIOMET, INC.