Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2013 - (Recall #: Z-1595-2013)

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 II KIT, REF 7510800AUS, 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-1595-2013

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: 2090 units

Code Information:

Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM

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