Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
FDA device recall Z-1321-2024 · posted 2024-03-20 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- Reason for recall
- Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
- Action taken
- On 02/09/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via US certified mail to customers to inform them that the abutment was manufactured with a dimensional condition that may lead to reduced engagement between the prosthetic screw and the implant. Customer are instructed to inspect their inventory and discard or return the affected products to PREAT CORPORATION. For questions or further assistance contact the Quality Assurance Manager at 800-232-7732 or email at nfetterman@younginnovations.com On 2/16/2024, the firm sent via certified USPS mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" which informs customer to notify all personnel within their company, and of their customers where the affected products may have been further distributed of the recall.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 561 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, OH and PA.
- Date initiated
- 2024-02-09
- Date posted
- 2024-03-20
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K183518) | Preat Corporation | 2019-03-18 |