Recall Z-0139-2007
DePuy Spine, Inc. · initiated October 10, 2006
Product
Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001
Codes / lots: All lot numbers except those beginning with '6' or ending with the letter 'R'
Reason for recall
Sterility of device is compromised due to loss of package integrity
FDA-determined 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.
Details
- Recall number
- Z-0139-2007
- Initiated
- October 10, 2006
- Posted by FDA
- November 2, 2006
- Terminated
- March 27, 2017
- Product code
- HWC – Screw, Fixation, Bone
- 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
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0130-2007 | DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0131-2007 | 0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0132-2007 | 12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0133-2007 | Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0134-2007 | Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0135-2007 | Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HISterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0136-2007 | Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HISterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0137-2007 | Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0138-2007 | Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0140-2007 | Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0141-2007 | Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0142-2007 | Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0143-2007 | Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |
| Z-0144-2007 | HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020Sterility of device is compromised due to loss of package integrity | 10/10/2006Terminated |