ModerateClass IIOngoing

FDA Devices recall · Reported August 28, 2024

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, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm D

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2687-2024.

Q: Where was the recalled product distributed?

Distribution: U.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

Recall #: Z-2687-2024
Affected scope: 185 devices
Initiated: June 25, 2024

Compiled from official public sources by the publisher. · Updated September 2026

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Preat Corp recalled Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digi… - a moderate-severity action.

Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digi… was recalled by Preat Corp in August 28, 2024. Reason: Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to v…. Check the official notice for the remedy. Verify recall #Z-2687-2024 with the FDA Devices before acting.

The recall

Preat Corp issued this moderate-severity FDA Devices recall-Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to v….

Moderate
severity level: 185 units
affected scope: Class II
classification: August 28, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2687-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

Reason for recall

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2687-2024
Date reported	August 28, 2024
Date initiated	June 25, 2024
Recalling firm	Preat Corp
Firm location	Santa Maria, CA
Affected scope	185 devices
Distribution	U.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

185 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2687-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2687-2024.

Where was the recalled product distributed? ▼

Distribution: U.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported August 28, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026