NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling
Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.
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: The recall involves a risk-of-harm product where potential injury (nerve damage or artery perforation) is described, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Nobel Biocare Services AG is recalling 188 units of NobelReplace Conical Connection (CC) PMC RP 4.3x10mm dental implants, reference number 37291. The recall is due to a labeling error where the implant cap incorrectly indicates measurements of 5.0x8mm, while the actual implant measurements are 4.3x10mm.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida and New York) and in Albania and Hong Kong. The specific lot number is 13084072.
If the incorrect label is not noticed prior to implant placement, it could lead to a second surgical procedure or the need for implant replacement. In cases where the implant is placed in the posterior lower jaw, the discrepancy may cause damage to the inferior alveolar nerve canal or perforate a small artery, requiring immediate implant removal. Consumers and healthcare providers should verify the actual measurements of these implants before use.
The recalled product
- Product
- NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
- Manufacturer
- NOBEL BIOCARE SERVICES AG
- Category
- Medical Device — Dental Implants
- Affected units
- 188
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 (2)
- Lot: 13084072
- UDI: (01)07332747073584(10)13084072(17)240525
Distribution
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