Recall Z-2855-2020
Globus Medical, Inc. · initiated July 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
Codes / lots: Part #: 1124.1032; Lot # / UDI #: BAX095XE / (01)00889095069549(10)BAX095XE; BAX175CE / (01)00889095069549(10)BAX175CE; BAX185BE / (01)00889095069549(10)BAX185BE; BAX299LE / (01)00889095069549(10)BAX299LE
Reason for recall
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
FDA-determined cause: Nonconforming Material/Component
Action taken
A customer letter dated July 22, 2020 was mailed to customers. In this letter customers are instructed to immediately examine their inventory and determine if they have any of the affected implants. Alternatively, they may return all ALTERA inventory and Globus will sort out the affected implants and replace inventory with conforming implants. Report any adverse effects believed to be associated with the product to Globus Medical immediately by filling out the attached Response Card.
Details
- Recall number
- Z-2855-2020
- Initiated
- July 22, 2020
- Posted by FDA
- August 22, 2020
- Terminated
- August 19, 2021
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Distribution
- Worldwide Distribution
- Recalling firm
- Globus Medical, Inc., Audubon, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2850-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2851-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2852-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2853-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2854-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2856-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2857-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2858-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2859-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2860-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2861-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2862-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2863-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2864-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2865-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2866-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2867-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2868-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2869-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2870-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |
| Z-2871-2020 Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15Specific lots of ALTERA implants have internal components that may have been manufactured using stainless… | 07/22/2020Terminated |