Medtronic Grafton DBM Crunch surgical implant packaging inspection defect
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This surgical implant device has potential packaging non-conformances and qualifies as a risk-of-harm product. Per the severity rubric, score 3 applies because no injuries have been reported, meeting the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Crunch (Model T44115), a demineralized bone matrix used in orthopedic and spinal surgical procedures. Eighty-four units are affected.
The recall was initiated because a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. As a result, affected units may have been distributed with potential non-conformances in the outer Tyvek pouch.
The affected products have been distributed to the United States, Colombia, South Korea, New Zealand, India, and Taiwan. Healthcare facilities and practitioners should verify the serial numbers of any Grafton DBM Crunch units in their inventory against the list of recalled serial numbers (GTIN 00643169123113). Products matching the recalled serial numbers should not be used.
Patients who have received this implant should speak with their healthcare provider if they have concerns about the recall.
The recalled product
- Product
- Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169123113
- Serial Numbers: A59083-054
- A59083-055
- A59083-056
- A59083-057
- A59083-058
- A59083-059
- A59083-060
- A59083-061
- A59083-062
- A59083-063
- A59083-064
- A56737-049
- A56737-050
- A56737-051
- A56737-052
- A56737-053
- A56737-054
- A56737-055
- A56737-056
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- SevereMedtronic Recalls Grafton DBM Products Due to Donor Microbial Presence
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- HighExpandable spinal cages recalled because they may lose height or collapse
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- ModerateGrafton DBM Matrix Strips Recalled for Packaging Inspection Defect
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
Same hazard · packaging defect
See all →- High
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