Recalls / —

—#49187

Product

Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

FDA product code

LYS — Bone Mill

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935

Why it was recalled

Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

Root cause (FDA determination)

Other

Action the firm took

The firm notified its consignees of the problem and the recall by letter delivered via overnight mail on 10/20/2006. The firm''s overseas distributors were also notified via electronic mail on 10/20/2006. The notices requested the discontinuation of use and stated that sales representatives would be retrieving the devices from them.

Recalling firm

Firm

Medtronic Sofamor Danek USA Inc

Address

1800 Pyramid Place, Memphis, Tennessee 38132-1719

Distribution

Distribution pattern

Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.

Timeline

Recall initiated

2006-10-20

Posted by FDA

2006-11-14

Terminated

2007-04-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49187. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.