Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville

FDA device recall Z-1323-2009 · posted 2009-05-27 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

HRS

Quantity affected

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, Aust

Date initiated

2009-03-20

Date posted

2009-05-27

Date terminated

2009-09-11

Location

Jacksonville, FL

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