BioHorizons Implant Systems Inc One Perimeter Park South BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
Brand
BioHorizons Implant Systems Inc One Perimeter Park South
Lot Codes / Batch Numbers
Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002
Products Sold
Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002,
BioHorizons Implant Systems Inc One Perimeter Park South is recalling BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgic due to Dental implants were distributed which lacked the proper instruments for implantation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dental implants were distributed which lacked the proper instruments for implantation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026