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Class 2 Device Recall GRAFTON DBM (Gel, Flex, Putty, Matrix, Crunch) |
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Date Initiated by Firm |
September 26, 2023 |
Date Posted |
October 25, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0163-2024 |
Recall Event ID |
93163 |
510(K)Number |
K051195
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Product Classification |
Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
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Product |
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix |
Code Information |
a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012;
b) T42210: GTIN 00643169123069, Serial Numbers: A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039, A57362-018, A58518-032, A58518-033, A58518-034, A58133-031, A58518-028, A59200-023, A59200-024, A57362-020, A57362-021, A57362-022, A58122-024, A58122-025, A58518-026, A58545-021, A59200-025, A59200-026, A58545-019, A58545-020, A58133-032, A58133-033, A58133-035, A58518-027, A59200-027, A58133-034, A59122-014, A57344-011, A57344-012, A57344-014, A57344-015, A57344-016, A59200-028, A58545-025, A58545-026, A58545-027, A58518-030, A58133-037, A58133-038, A58518-029, A59122-015, A59122-016, A57387-025, A57362-023, A57362-024, A57362-025, A58122-026, A58122-027, A58122-028, A58122-029, A59122-011, A59122-012, A59122-013 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Pl Memphis TN 38132-1703
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Manufacturer Reason for Recall |
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
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FDA Determined Cause 2 |
Employee error |
Action |
Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices. |
Quantity in Commerce |
377 units |
Distribution |
US, Colombia, S. Korea, New Zealand, India, Taiwan |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = MBP and Original Applicant = OSTEOTECH, INC.
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