Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) D

Recall Insight

This FDA Devices action (record #Z-1326-2023) was formally reported on April 12, 2023, with the manufacturer initiating the action on February 8, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Sofamor Danek USA Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records indicate 30541 units units are affected.

The documented reason for this recall is: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Irel…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.