—#167644

Product

INFUSE Bone Graft X SMALL KIT REF 7510100

FDA product code: NEK — Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P000058, P050053
Affected lot / code info: UDI 00613994239525, Lot Number M111806AAA

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2018-09-27
Terminated: 2020-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167644. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.