Nobel Biocare USA LLC NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
Brand
Nobel Biocare USA LLC
Lot Codes / Batch Numbers
Ref 32216 lot number: 403504
Products Sold
Ref 32216 lot number: 403504
Nobel Biocare USA LLC is recalling NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended due to This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. T. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
Recommended Action
Per FDA guidance
The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products. Contact Kam Leung at 714-282-4800 if you have questions.
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 noticeDistribution
As reported by FDA
AZ, AR, CA, CO, FL, GA, IL, IA, ME, MA, MI, MO, NJ, NY, NC, OK, PA, TX, UT, VA, WA
Page updated: Jan 10, 2026