Z-0136-2007

Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI

Name: Z-0136-2007 Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI
Creator: DePuy Spine, Inc.
Published: 2006-10-10
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2006-10-10 / Terminated / root cause: packaging

FDA source

DePuy Spine, Inc. began a recall of Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI on 2006-10-10. The reason FDA records is "Sterility of device is compromised due to loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0136-2007
Status: Terminated
Initiated: 2006-10-10
Posted: 2006-11-02
Terminated: 2017-03-27
Recalling firm: DePuy Spine, Inc.
Product: Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI
Product code: HWC Screw, Fixation, Bone
Reason for recall: Sterility of device is compromised due to loss of package integrity
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 1720 units
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
Product codes and lots: All lot numbers except those beginning with '6' or ending with the letter 'R'

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)