MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.
FDA Recall Z-1997-2009 · Posted 2009-09-10
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Recalling FirmIMTEC Corporation
Recall StatusTerminated
Product CodeKKO
Date Initiated2009-07-07
Date Terminated2009-12-02
Product Quantity605 units
Reason for Recall
Size printed on product packaging does not match size of enclosed product.
Firm Action
A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.
Root Cause
Other
Distribution Pattern
Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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