Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002
FDA device recall Z-0138-2007 · posted 2006-11-02 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- Reason for recall
- Sterility of device is compromised due to loss of package integrity
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 157 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, Chil
- Date initiated
- 2006-10-10
- Date posted
- 2006-11-02
- Date terminated
- 2017-03-27
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BREMER HALO SYSTEM TITANIUM SKULL PIN (K993099) | Depuyacromed | 1999-12-15 |
| BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN (K915800) | Bremer Medical, Inc. | 1992-03-16 |