Reported Aug 26, 2020 · Terminated
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in…
Nobel Biocare Services Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NOBEL BIOCARE SERVICES AG · Balz-zimmermannstrasse 7 · Kloten, N/A · N/A
Is this the product you have?
- NobelReplace Conical Connection (CC) PMC RP 4.3x10mm
- REF37291 -
- Product Usageimplants 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
- Lot codes and dates
- Lot13084072
- UDI(01)07332747073584(10)13084072(17)240525
- Amount recalled
- 188
Where it was sold
Why it was recalled
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
This product could cause temporary or reversible health problems — stop using it.
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