NobelReplace dental implant components recalled for driver engagement defect
Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of dental implant components with 16 confirmed complaints of improper device engagement due to manufacturing defect. While no patient injuries have been reported, the defect presents a risk of surgical failure or delay, meeting the criterion for high-severity risk-of-harm product.
Plain-English summary
Nobel Biocare Usa Llc is recalling 702 units of NobelReplace Conical Connection RP 4.3x11.5 mm dental implant components (Catalog Number 36707, Lot Numbers 13116495, 13116496, 13116497). The affected components were distributed nationwide in the United States, Canada, Mexico, and Turkey.
The recall results from 16 complaints that the surgical driver does not engage properly with the implant. The manufacturer's investigation determined that an incorrect offset gauge was potentially used during production, preventing proper driver engagement.
This defect could result in aborted or delayed surgical procedures.
The recalled product
- Product
- NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Affected units
- 702
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- (01)07332747160529(10)13116496(11)210720(17)260618
- (01)07332747160529(10)13116497(11)210720(17)260618
- Lot Numbers: 13116495
- 13116496
- 13116497
Distribution
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