Grafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
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 FDA Class II recall involves a potential sterile packaging defect on an implantable surgical device with no reported illnesses or injuries. The theoretical hazard on a risk-of-harm product meets the criterion for High severity when injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling certain batches of Grafton DBM Orthoblend (model numbers T44125INT, T44135, T44145, and T44150), a demineralized bone matrix used in orthopedic and spinal fusion procedures.
The recall was initiated because a required inspection step for the sterile outer Tyvek pouch may not have been performed according to specifications. This quality control step is essential for ensuring the integrity of the sterile packaging. As a result, batches may have been released with potential non-conformances in the outer Tyvek pouch.
The recalled products were distributed in the United States, Colombia, South Korea, New Zealand, India, and Taiwan. Healthcare facilities and distributors in possession of the affected serial numbers should contact Medtronic Sofamor Danek USA Inc for instructions regarding returns or replacements.
The recalled product
- Product
- Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 430
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)
- a) T44125INT: GTIN 00643169965058
- Serial Numbers: A52559-042
- A52559-024
- A52559-038
- A52559-039
- A52559-040
- A52559-041
- A52559-044
- A52559-045
- A52559-021
- A52559-022
- A52559-023
- A52559-025
- A52559-026
- A52559-027
- A52559-028
- A52559-029
- A52559-030
- A52559-031
- A52559-032
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
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- ModerateGrafton DBM Matrix Strips Recalled for Packaging Inspection Defect
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Same hazard · packaging defect
See all →- High
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