Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2013 - (Recall #: Z-1590-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Product Classification:

Class II

Date Initiated: May 28, 2013

Date Posted: July 3, 2013

Recall Number: Z-1590-2013

Event ID: 65297

Reason for Recall:

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Status: Terminated

Product Quantity: 8884 units

Code Information:

Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS

Distribution Pattern:

Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.

Voluntary or Mandated:

Voluntary: Firm initiated