DePuy Spine, Inc. HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020
Brand
DePuy Spine, Inc.
Lot Codes / Batch Numbers
All lot numbers except those beginning with '6' or ending with the letter 'R'
Products Sold
All lot numbers except those beginning with '6' or ending with the letter 'R'
DePuy Spine, Inc. is recalling HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020 due to Sterility of device is compromised due to loss of package integrity. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility of device is compromised due to loss of package integrity
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026