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All product recalls associated with Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.
Total Recalls
275
Past Year
5
Class I (Serious)
17
Most Recent
Dec 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 thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.