ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8
This recall has been terminated (originally issued August 22, 2020).
- Company
- Globus Medical, Inc.
- Recall Initiated
- July 22, 2020
- Posted
- August 22, 2020
- Terminated
- August 19, 2021
- Recall Number
- Z-2853-2020
- Firm Location
- Audubon, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution
Lot / Code Info
Part #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE
Root 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.