"***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.
FDA Recall Z-2849-2011 · Posted 2011-07-19
Advertisement
Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeKDD
Date Initiated2010-10-08
Date Terminated2012-04-19
Product Quantity82
Reason for Recall
Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
Firm Action
Biomet Microfixation (formerly W. Lorenz) sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices).
If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Root Cause
Pending
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement