LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
FDA Recall Z-0665-03 · Posted 2003-03-20
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Recalling FirmImplant Innovations, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2003-01-28
Date Terminated2012-05-03
Product Quantity68
Reason for Recall
Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
Firm Action
The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
Root Cause
Other
Distribution Pattern
Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
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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