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Terminated

INFUSE Bone Graft X SMALL KIT REF 7510100

FDA Recall Z-0440-2019 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeNEK
Date Initiated2018-09-27
Date Terminated2020-09-16
Product Quantity138 units

Reason for Recall

The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

Firm Action

The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.

Root Cause

Error in labeling

Distribution Pattern

US

Official Source

View FDA Recall →

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

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