FDA Medical Device Recalls (openFDA)
Preat Corp: Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
- Recall number
- Z-1321-2024
- Recalling firm
- Preat Corp
- Product
- Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
- Status
- Open, Classified
- Initiated
- 2024-02-09
- Posted
- 2024-03-20
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 561 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, OH and PA.
- Lot, serial or model codes
- Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
- 510(k) numbers
- ["K183518"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 2918719
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28