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Terminated

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15

FDA Recall Z-2864-2020 · Posted 2020-08-22

Recalling FirmGlobus Medical, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2020-07-22
Date Terminated2021-08-19

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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