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All product recalls associated with Integrated Orbital Implants Inc.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2006
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 threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.
The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.