FDA Device

Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. Th

Hazard

Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.

What You Should Do

Remedy

Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine.

Products

Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Gui
Brand
Zimmer Spine, Inc.
UPC
Part Number 07.00684.001, Lot numbers: P031530, P031650, P040389, P040111, P051160, P051161

Units Affected

159