FDA Device

Fix pins associated with Stealth Station Treatment Guidance Platform

Hazard

Surgical devices intended for single use were not labeled for single use.

What You Should Do

Remedy

Consignees were notified by letter on 11/01/2003.

Products

Fix pins associated with Stealth Station Treatment Guidance Platform
Brand
Medtronic Surgical Navigation Tech, Inc
UPC
3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619.  5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.

Units Affected

127 devices