Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws
Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.
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 medical device where a component failure (screw loosening) poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Nobel Biocare USA LLC is recalling 215 pieces of Snappy Abutment 5.5 CC RP 3 mm, catalog no. 36683, lot no. 13077700. These pre-manufactured prosthetic components are intended to be used in the upper or lower jaw to support tooth replacements and restore chewing function.
The recall was initiated because packages of these abutments may contain an incorrect screw. While the incorrect screw will tighten, it cannot be guaranteed that it will not loosen. If the screw loosens, the abutment should be retightened with the correct screw.
The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Canada, China, and Germany. Consumers and healthcare providers should check their inventory for the specific catalog and lot numbers listed above. If the product is found, it should be stopped from use and the abutment retightened with the correct screw if necessary.
The recalled product
- Product
- Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Affected units
- 215
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 (3)
- Catalog no. 36683
- Lot no. 13077700
- UDI: (01)07332747034264(10)13077700
Distribution
Part of a larger recall action
This product is one of 6 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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