FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001
- Recall number
- Z-0139-2007
- Recalling firm
- DePuy Spine, Inc.
- Product
- Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001
- Status
- Terminated
- Initiated
- 2006-10-10
- Posted
- 2006-11-02
- Terminated
- 2017-03-27
- Reason
- Sterility of device is compromised due to loss of package integrity
- 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
- 87 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
- Lot, serial or model codes
- All lot numbers except those beginning with '6' or ending with the letter 'R'
- 510(k) numbers
- ["K915800","K993099"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28