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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

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 Class 2 Recall
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
see related information
Date Posted May 27, 2009
Recall Status1 Terminated on September 11, 2009
Recall Number Z-1323-2009
Recall Event ID 51668
Premarket Notification
510(K) Number
K071577 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL. LactoSorb® Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity.
Code Information All lots.
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction.
FDA Determined
Cause 2
DESIGN: Device Design
Action An "Urgent Medical Device Recall Notice" was issued via certified letter or email on March 20, 2009 to consignees. Customers were instructed to immediately remove and return the affected in-stock product to Biomet Microfixation, Inc. Customers were also asked to complete and return the enclosed Inventory Reconciliation sheet via fax (904-741-9425) to the firm, and to notify recipients of any recalled products that had been further distributed. For questions about the recall, contact Biomet Microfixation at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm EST.
Quantity in Commerce 2,117
Distribution Worldwide Distribution -- US (including DC and states of AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MI, MO, MN, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA and WI) and countries of Argentina, Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Israel, Italy, Lativa, Netherlands, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = BIOMET MICROFIXATION, INC.
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