Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2013 - (Recall #: Z-1589-2013)

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, SMALL KIT, REF 7510200, 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-1589-2013

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: 22936 units

Code Information:

Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE

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