The label, instructions, or markings were wrong or out of date. The FDA lists 37 recalls with this root cause since 2025. Most recent report: Sep 23, 2026.
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, imp…
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Component labeling discrepancy
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.