Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65297

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Sofamor Danek USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1589-2013
Recall number
Z-1589-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
22936 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

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.

device · product 2 of 7

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1590-2013
Recall number
Z-1590-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
8884 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Code information

Lots: M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, M111064AAS

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.

device · product 3 of 7

INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1591-2013
Recall number
Z-1591-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
4885 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

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.

device · product 4 of 7

INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1592-2013
Recall number
Z-1592-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
16994 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Code information

Lots: M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, M111059AAD

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.

device · product 5 of 7

INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1593-2013
Recall number
Z-1593-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
1319 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Code information

Lots: M111063AAK, M111064AAH, M111063AAE, M111063AAO

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.

device · product 6 of 7

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1594-2013
Recall number
Z-1594-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
400 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Code information

Lots: M111063AAF, M111064AAN

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.

device · product 7 of 7

INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Z-1595-2013
Recall number
Z-1595-2013
Initiated
May 28, 2013
Classification
Class II
Status
Terminated
Quantity
2090 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

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.