CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report
Infuse(R) Bone Graft, Large II Kit recalled
Medtronic Sofamor Danek USA is recalling Infuse(R) Bone Graft, Large II Kit, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1595-2013
- FDA event ID
- 65297
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2013
- FDA classified
- 25 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Device type
- Hip & Knee Implants
Timeline
| 28 May 2013 | Recall initiated by company | |
| 25 Jun 2013 | Classified by FDA | +28 days |
| 3 Jul 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Product as listed by the FDA
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Which lots are affected?
Lots: M111103AAC, M111052AAT, M111059AAE, M111054AAR, M111052AAM
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 65297This product is part of a recall event; the main page for the event is Infuse(R) Bone Graft, Small Kit recalled by Medtronic Sofamor Danek USA.
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