Preat Nobel RP Titanium Abutment Blank Recalled for Manufacturing Defect
Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.
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 recall with no reported hospitalizations, injuries, or illnesses. The defect presents a structural risk to implant stability but falls under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Preat Corp is recalling 561 units of the Nobel Active/Conical-compatible RP Titanium Abutment Blank (Model 9000967, UDI-DI 00842092165867) due to a manufacturing defect. The product was distributed nationwide in Arizona, Ohio, and Pennsylvania.
The recall is due to a manufacturing issue affecting the screw seat location on the abutment. The screw seat may be positioned too high, causing the mating screw to have a shorter engagement length into the associated implant. This may affect the stability and performance of the implant assembly.
Healthcare providers in the affected states who have used or distributed this abutment should verify whether they have affected units based on the lot numbers: 235650, 234294, 233667, 233885, 233439, and 231489.
The recalled product
- Product
- Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
- Manufacturer
- Preat Corp
- Affected units
- 561
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 (6)
- Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650
- 234294
- 233667
- 233885
- 233439
- and 231489
Distribution
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