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.
This recall has been terminated (originally issued May 27, 2009).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- March 20, 2009
- Posted
- May 27, 2009
- Terminated
- September 11, 2009
- Recall Number
- Z-1323-2009
- Quantity
- 2,117
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All lots.
Root Cause
Device Design
Action Taken
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.