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All product recalls associated with Synthes Spine.
Total Recalls
104
Past Year
1
Class I (Serious)
1
Most Recent
Sep 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
the dimensional specifications are incorrect
The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization parameter is a minium of 24 minutes prevacuum.
Hole is malformed, leading to reduced construct strength.
Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.