Dental Digital Analog Products Recalled for Out-of-Specification Rotation
Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.
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: FDA Class II recall with a documented manufacturing defect affecting measurement accuracy. No illnesses, injuries, or hospitalizations have been reported. The hazard is indirect—potential laboratory errors from inaccurate inspection—not direct patient harm, placing this in the Moderate category.
Plain-English summary
Preat Corp has recalled 185 dental digital analog products distributed nationwide due to a manufacturing issue causing out-of-specification rotation. The affected products are used by dental laboratories for visual inspection of dental abutment components and restorations.
Digital analogs serve as reference tools to visually inspect dental abutment components and restorations. When misaligned due to the manufacturing defect, these tools may not accurately represent the dental components being inspected, potentially affecting the accuracy of laboratory work and clinical outcomes.
The recall includes multiple models compatible with NobelBiocare, Straumann, 3i, Astra, BioHorizons, and Legacy implant systems. The 185 recalled devices were distributed nationwide across 18 U.S. states: AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA. Specific model numbers and lot numbers have been identified.
Dental laboratories and clinicians using these digital analogs should contact Preat Corp regarding replacement or remediation. No injuries or adverse events have been reported to date.
The recalled product
- Product
- Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
- Manufacturer
- Preat Corp
- Affected units
- 185
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 (20)
- Model Numbers: 9000703
- 9001303
- 9001903
- 9002003
- 9002103
- 9002203
- 9005203
- 9005303
- 9005403
- 9005503
- 9008503
- 9006767 UDI-DI codes: 00842092178690
- 00842092181898
- 00842092181959
- 00842092178737
- 00842092178775
- 00842092178812
- 00842092178898
- 00842092178997
- 00842092178928
Distribution
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