Recall Z-1851-2020— Nobel Biocare Usa Llc
Class II · Terminated
Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-08-28, terminated 2021-04-28. It names one FDA 510(k) clearance: K173418. Product: NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: 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.. Reason: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm)..
- Recalling firm
- Nobel Biocare Usa Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-28
- Terminated
- 2021-04-28
- Firm location
- Yorba Linda, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: 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.
Reason for recall
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Data sourced from openFDA. This site is unofficial and independent of the FDA.