HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020
- Company
- Depuy Spine, Inc.
- Recall Initiated
- October 10, 2006
- Posted
- November 2, 2006
- Terminated
- March 27, 2017
- Recall Number
- Z-0144-2007
- Quantity
- 635 units
- Firm Location
- Raynham, MA
Reason for Recall
Sterility of device is compromised due to loss of package integrity
Distribution
Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia
Lot / Code Info
All lot numbers except those beginning with '6' or ending with the letter 'R'
Root Cause
Other
Action Taken
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.
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