Z-1595-2013Class II

INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place...

Name: Z-1595-2013 INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2013-05-28
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2013-05-28 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic on 2013-05-28. FDA classified it as Class II and gives the reason as "Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1595-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-06-25
Terminated: 2014-05-13
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Product code: NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Reason for recall: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic on behalf of Integra LifeSciences Corporation sent an Urgent Voluntary Removal (Recall) letter on May 24, 2013, directly to all Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. Foreign consignees were notified by email on May 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product and discontinue use. The letter should be forwarded to surgeons or attending physicians who have used the affected products. Customers were instructed to use the attached questionnaire to account for product in their possession, document which physicians they notified and report any patient injuries that may have occurred related to the use of the affected product by calling the phone number in the questionnaire. Customers were asked to return the questionnaire using the enclosed self-addressed stamped envelope, via their Medtronic Sales Representative or via fax to 763-367-8134 For questions regarding this recall 901-399-3182. Customers were instructed to contact their Medtronic Sales Representative to coordinate the return and replenishment of affected product . Customers with questions should call 800-876-3133, ext 3197.
Quantity in commerce: 2090 units
Distribution: 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.
Product codes and lots: Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1595-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1589-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1590-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1591-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1592-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1593-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1594-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1595-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25

Product code NEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)