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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1323-2023 - 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 5C...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1324-2023 - 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...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1325-2023 - 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...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1326-2023 - 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;...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1327-2023 - 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;...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1334-2023 - 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 XPAN...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1329-2023 - 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 PAST...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1330-2023 - 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 GRAFTO...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1331-2023 - 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 M...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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Z-1332-2023 - 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...
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2
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04/04/2023
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Medtronic Sofamor Danek USA Inc
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