Medtronic Sofamor Danek USA Inc. is recalling 1,833 units of Grafton DBM (Demineralized Bone Matrix) products, including Crunch, Flex, Matrix, Matrix Strips, Orthoblend, Paste, and Putty varieties. The recall was initiated because a critical inspection step for the outer Tyvek pouch may not have been performed correctly during manufacturing. This defect could result in the release of products with compromised packaging, potentially impacting the sterile barrier of these surgical bone graft materials. Consumers and healthcare providers should check for specific serial numbers across multiple model lines, including T44115, T42100, T42200, T42210, T42275, T42280, T44125INT, T44135, T44145, T44150, T45001, T45005, T45010, T43102, T43103INT, T43105, T43105INT, T43110, and T43110INT. If you have these products in stock, please contact Medtronic for further instructions and potential return.
A failure in the inspection of the outer Tyvek pouch means the product's sterile barrier may be compromised. Use of a non-conforming pouch in a surgical setting could potentially lead to infection or other complications for the patient receiving the bone matrix graft.
Quarantine and Manufacturer Coordination
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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