Recalls / —

—#53652

Product

BacT/ALERT FN Culture Bottles, Product Number 259793

FDA product code

MBD — Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Device class

Class 3

Medical specialty

Unknown

510(k) numbers

K992432

Affected lot / code info

Product number 259743, Lot 1015145

Why it was recalled

Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom

Timeline

Recall initiated

2007-02-16

Posted by FDA

2007-08-22

Terminated

2009-12-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #53652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.