Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2013 - (Recall #: Z-1591-2013)

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, LARGE KIT, REF 7510600, 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-1591-2013

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: 4885 units

Code Information:

Lots: M111052AAE, M111052AAN, M111052AAS, M111052AAD, M111059AAA

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