Dental abutment recall due to incorrect product packaging and labeling
Preat Corp recalled 7 units of 9006767 Astra EV 4.8mm Milled Titanium Abutments due to incorrect products being packaged and labeled. Affected units were distributed in California, Missouri, and Nevada.
What this means for you
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: This is an FDA Class II medical device where incorrect products were packaged and labeled, creating a risk-of-harm situation if the wrong abutment component is used with an implant system. No illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Preat Corp has recalled 7 units of the 9006767 Astra EV 4.8mm Milled Titanium Abutment due to incorrect abutments being packaged and labeled. Milled abutments are used with endosseous dental implant fixtures to support prosthetic teeth restoration.
The recalled units (Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165, and 241588) were distributed in California, Missouri, and Nevada. Because the incorrect abutments were packaged with incorrect labeling, dental professionals and patients may receive the wrong component for their specific implant system.
Dental professionals who have received or dispensed products from the affected lot numbers should contact Preat Corp immediately to identify and replace any incorrect units before use. Patients who have undergone treatment with an abutment from the affected lots should contact their dental provider to verify that the correct component was used.
The recalled product
- Product
- 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
- Manufacturer
- Preat Corp
- Hazard
- packaging-error
- mis-labeling
- incorrect-product-packaged
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)
- Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825
- ED11-20248895
- ED11-20249165 and 241588
Distribution
Distributed in 3 states:
- CA
- MO
- NV
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