FDA Device

DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100

Hazard

Sterility of device is compromised due to loss of package integrity

What You Should Do

Remedy

DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.

Products

DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100
Brand
DePuy Spine, Inc.
UPC
All lot numbers except those beginning with '6' or ending with the letter 'R'

Units Affected

715 units