Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2

Summary

The FDA issued a Class II for Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S4 by Medtronic Sofamor Danek USA Inc. Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a .

Details

Product Description

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 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product

Lot/Code Info: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693, A42811, A43336, A43592, A44884, A44960; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210, GTIN 00613994960948, Serial Numbers: A42415, A42482, A42953, A43212, A43354, A43965, A44760, A45028, A46673, A48105, A48484, A49062, A49564, A50856, A52420, A52719, A52904, A53373; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200, GTIN 00643169123052, Serial Numbers: A38910-046, A38910-047, A38910-048, A38910-049, A38910-050, A38910-051, A38910-052, A38910-053, A38910-054, A38910-055, A38910-056, A38910-057, A39374-061, A39374-062, A39374-063, A39374-064, A39374-065, A39374-066, A39374-067, A39374-068, A39374-069, A39374-070, A39374-071, A39374-072, A39736-021, A39736-022, A39736-023, A39736-024, A39736-025, A39736-026, A39736-027, A39736-028, A39736-029, A39736-030, A39736-031, A39736-032, A39803-051, A39803-052, A39803-053, A39803-054, A39803-055, 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A45882-014, A45882-015, A45882-016, A45882-017, A45882-018, A45882-019, A45882-020, A45887-022, A45887-023, A45887-024, A45887-025, A45887-026, A45887-027, A45887-028, A45887-029, A45887-030, A45887-031, A45887-032, A45966-011, A45966-012, A45966-013, A45966-014, A45966-015, A45966-016, A45966-017, A45966-018, A45966-019, A45966-020, A45966-021, A46003-011, A46003-012, A46003-013, A46003-014, A46003-015, A46003-016, A46003-017, A46003-018, A46003-019, A46020-011, A46020-012, A46020-013, A46020-014, A46020-015, A46020-016, A46020-017, A46020-018, A46020-019, A46020-020, A46020-021, A46033-028, A46033-029, A46033-030, A46033-031, A46033-032, A46033-033, A46033-034, A46033-035, A46033-036, A46033-037, A46033-038, A46035-011, A46035-012, A46035-013, A46035-014, A46035-015, A46035-016, A46035-017, A46035-018, A46035-019, A46035-020, A46035-021, A46085-011, A46085-012, A46085-013, A46085-014, A46085-015, A46085-016, A46085-017, A46085-018, A46085-019, A46085-020, A46085-021, A46087-011, A46087-012, A46087-013, A46087-014, A46087-015, A46087-016, A46087-017, A46087-018, A46087-019, A46087-020, A46116-041, A46116-042, A46116-043, A46116-044, A46116-045, A46116-046, A46116-047, A46116-048, A46127-011, A46127-012, A46127-013, A46127-014, A46127-015, A46127-016, A46127-017, A46127-018, A46127-019, A46127-020, A46147-011, A46147-012, A46147-013, A46147-014, A46147-015, A46147-016, A46147-017, A46147-018, A46147-019, A46163-011, A46163-012, A46163-013, A46163-014, A46163-015, A46163-016, A46163-017, A46163-018, A46173-041, A46173-042, A46173-043, A46173-044, A46173-045, A46173-046, A46173-047, A46173-048, A46173-049, A46173-050, A46173-051, A46174-136, A46174-137, A46174-138, A46174-139, A46174-140, A46174-141, A46174-142, A46174-143, A46174-144, A46174-145, A46174-146, A46174-147, A46189-011, A46189-012, A46189-013, A46189-014, A46189-015, A46189-016, A46189-017, A46189-018, A46189-019, A46189-020, A46189-021, A46189-022, A46193-011, A46193-012, A46193-013, A46193-014, A46193-015, A46193-016, A46193-017, A46193-018, A46193-019, A46193-020, A46193-021, A46198-011, A46198-012, A46198-013, A46198-014, A46198-015, A46198-016, A46198-017, A46198-018, A46201-011, A46201-012, A46201-013, A46201-014, A46201-015, A46201-016, A46212-011, A46212-012, A46212-013, A46212-014, A46212-015, A46212-016, A46212-017, A46212-018, A46212-019, A46214-011, A46214-012, A46214-013, A46214-014, A46214-015, A46214-016, A46214-017, A46214-018, A46215-011, A46215-012, A46215-013, A46215-014, A46215-015, A46215-016, A46215-017, A46215-018, A46215-019, A46221-051, A46221-052, A46221-053, A46221-054, A46221-055, A46221-056, A46221-057, A46221-058, A46221-059, A46221-060, A46221-061, A46244-011, A46244-012, A46244-013, A46244-014, A46244-015, A46244-016, A46244-017, A46244-018, A46244-019, A46247-011, A46247-012, A46247-013, A46247-014, A46247-015, A46247-016, A46247-017, A46247-018, A46247-019, A46247-020, A46247-021, A46250-011, A46250-012, A46250-013, A46250-014, A46250-015, A46250-016, A46250-017, A46250-018, A46250-019, A46250-020, A46250-021, A46250-022, A46263-011, A46263-012, A46263-013, A46263-014, A46263-015, A46263-016, A46263-017, A46286-011, A46286-012, A46286-013, A46286-014, A46286-016, A46286-017, A46286-018, A46310-011, A46310-012, A46310-013, A46310-014, A46310-015, A46310-016, A46310-017, A46310-018, A46310-019, A46310-020, A46310-021, A46342-011, A46342-012, A46342-013, A46342-014, A46342-015, A46342-016, A46342-017, A46358-011, A46358-016, A46358-017, A46358-018, A46387-012, A46387-013, A46387-014, A46387-015, A46397-011, A46397-012, A46397-013, A46397-014, A46397-015, A46397-016, A46397-017, A46397-018, A46397-019, A46397-020, A46397-021, A46397-022, A46397-023, A46397-024, A4640

Quantity Affected: 19057 units

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-08

Company