Nobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error
Nobel Biocare is recalling 149 units of Zirconia Abutment Retrieval Instruments and Kits because a dimensional error prevents the instruments from removing metal adapters as intended.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (incorrect dimension) that prevents the instrument from working as intended, without reporting any injuries or illnesses. This aligns with the 'Moderate' severity criteria for low-risk issues or voluntary precautionary recalls where harm is not reported.
Plain-English summary
Nobel Biocare USA LLC is recalling 149 units of the Abutment Retrieval Instrument Zirconia CC RP/WP (Article No. 37882) and the Abutment Retrieval Kit (Article No. 37508). The affected instruments are used to remove zirconia abutments that are stuck in implant connections due to a tight seat. The recall covers specific batches: Article No. 37882, Batch No. 96149, and Article No. 37508, Batch Nos. 814929, 815096, 815140, and 855021.
The recall was initiated because one dimension of the affected instrument is incorrect. As a result, the instrument cannot be used to remove the metal adapter as intended. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed worldwide, including in the United States (nationwide) and in Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and the United Kingdom. Healthcare professionals should stop using the affected instruments and contact Nobel Biocare for further instructions.
The recalled product
- Product
- Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous
- Manufacturer
- Nobel Biocare Usa Llc
- Hazard
- Affected units
- 149
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 (7)
- Article No. 37882
- Batch No. 96149
- Article No. 37508
- Batch No. 814929
- 815096
- 815140
- and 855021.
Distribution
Distributed nationwide across the United States.
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