Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DC500 LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DC500 LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE
Brand
Implant Innovations, Inc.
Lot Codes / Batch Numbers
Lot # 219630
Products Sold
Lot # 219630
Implant Innovations, Inc. is recalling Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tra due to The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
Recommended Action
Per FDA guidance
The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.
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