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Open, Classified

Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

FDA Recall Z-0161-2024 · Posted 2023-10-25

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusOpen, Classified
Product CodeMBP
Date Initiated2023-09-26
Product Quantity84 units

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051195GRAFTON DBMOsteotech, Inc. · 2005-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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