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.
What this means for you
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
- packaging-defect
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.
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