ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
FDA device recall Z-2866-2020 · posted 2020-08-22 · Terminated
Recall details
- Recalling firm
- Globus Medical, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MAX
- Distribution
- Worldwide Distribution
- Date initiated
- 2020-07-22
- Date posted
- 2020-08-22
- Date terminated
- 2021-08-19
- Location
- Audubon, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALTERA SPACER (K140411) | Globus Medical, Inc. | 2014-07-01 |