Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect may cause 'permanent nerve damage' and 'additional surgery,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4 (Severe).
Plain-English summary
Nobel Biocare USA LLC is recalling 221 units of NobelActive Internal NP 3.5x15mm Endosseus dental implants (REF: 34128, Lot 13080792). The recall was initiated because the top label for the dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm).
The FDA has classified this as a Class II recall. An incorrectly sized implant may cause patient discomfort, permanent nerve damage, and may require an additional surgery. The affected products were distributed in the United States to the following states: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, and WI. No distribution outside the United States is reported.
Healthcare providers and patients should check their records for implants with REF 34128 and Lot number 13080792. If you have received or used these specific implants, contact your healthcare provider or Nobel Biocare for further instructions on how to proceed.
The recalled product
- Product
- NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 221
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 (1)
- Lot number: 13080792
Distribution
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