BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
FDA Recall Z-0252-2007 · Posted 2006-12-06
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Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2005-12-28
Date Terminated2007-08-11
Product Quantity470 units
Reason for Recall
Dental implants were distributed which lacked the proper instruments for implantation.
Firm Action
The firm initiated a recall on December 28, 2005 via US Mail. The letter explains the new implants introduced and explains the need for two additional instruments, the Handpiece and Ratchet Adapter, which are necessary to implant the new one-piece, ball-top 3.0mm diameter implant. A second letter was sent to all non-responding consignees on October 20, 2006 stating the same. The distributors were notified by electronic mail on 11/01/2006.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, Brazil, Canada, Chile, Colombia, Egypt, El Salvador, India, Israel, Italy, Ireland, Germany, Japan, Kuwait, Latvia, Lithuania, Mexico, Romania, Russia, Singapore, South Africa, Taiwan, United Arab Emirates, and United Kingdom.
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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