FDA (Devices) recall action 91697

Medtronic Sofamor Danek USA Inc recalled 12 products on 2023-04-12

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2023-04-12
Critical: 0
Units: 381,301

Why these products were recalled

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

HighFDA (Devices)··2023-04-12
Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
Product
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall
Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.
Product
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORT
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
Product
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
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HighFDA (Devices)··2023-04-12
Medtronic Grafton Plus Paste surgical implant recall due to packaging defects
Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.
Product
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T4500
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HighFDA (Devices)··2023-04-12
Medtronic Grafton Flex bone graft products recalled for packaging integrity defects
Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.
Product
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX G
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects
Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.
Product
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns
Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were distributed worldwide.
Product
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton Crunch sterile pouch packaging non-conformance recall
Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.
Product
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DB
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0 states
HighFDA (Devices)··2023-04-12
Medtronic Grafton Gel Surgical Implant Sterile Barrier Packaging Recall
Medtronic is recalling Grafton Gel demineralized bone matrix surgical implants due to packaging non-conformances in the sterile pouch that could compromise the sterile barrier of the implant.
Product
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120IN
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HighFDA (Devices)··2023-04-12
Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects
Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.
Product
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM
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HighFDA (Devices)··2023-04-12
Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.
Product
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
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HighFDA (Devices)··2023-04-12
Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
Product
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
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