Z-0162-2024Class II

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Name: Z-0162-2024 Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Creator: Medtronic Sofamor Danek USA Inc
Published: 2023-09-26
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2023-09-26 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix on 2023-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0162-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-26
Posted: 2023-10-25
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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.
Root cause tag: manufacturing process
FDA root cause: 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: 77 units
Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan
Product codes and lots: GTIN 00643169123007, Serial Numbers: A57164-040, A58820-011, A57164-041, A57164-042, A59190-046, A59190-041, A59190-042, A59190-043, A59190-044, A59190-045, A57164-026, A57164-027, A57164-028, A57164-029, A57164-030, A57164-031, A57164-032, A57164-033, A58820-017, A58820-018, A57164-011, A57164-012, A57164-013, A57164-014, A57164-015, A57164-016, A57164-017, A57164-018, A57164-019, A57164-020, A57164-021, A57164-022, A57164-023, A57164-024, A57164-025, A57164-034, A57164-035, A57164-036, A57164-037, A57164-038, A57164-039, A58820-012, A58820-013, A58820-014, A58820-015, A58820-016, A58820-019, A58820-020, A58820-021, A58820-022, A58820-023, A58820-024, A58820-025, A58820-026, A58820-027, A58820-028, A58820-029, A58820-030, A58820-031, A58820-033, A58820-034, A58820-035, A58820-036, A58820-037, A58820-038, A58820-039, A58820-040, A59190-031, A59190-032, A59190-033, A59190-034, A59190-035, A59190-036, A59190-037, A59190-038, A59190-039, A59190-040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0162-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0163-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0164-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0165-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0166-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0167-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24

Product code MBP

K051195Class IIGrafton DbmOsteotech, Inc. / cleared 2005-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)