Recall Z-1323-2009 · HRS Plate, Fixation, Bone

Biomet Microfixation, Inc.

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 repos

Date	May 27, 2009 (initiated Mar 20, 2009)
Status	Terminated
Reason	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.
Root cause	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	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
FDA record	Open on fda.gov

510(k) clearances named in this recall

K071577

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
Biomet Microfixation, Inc., Sep 6, 2007