Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Strauman

FDA device recall Z-2687-2024 · posted 2024-08-19 · Open, Classified

Recall details

Recalling firm

Preat Corp

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.

Action taken

On 07/22/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter via certified mail informing customers that Digital Analogs were manufactured out of specification for the rotational feature which may result in the dental restoration/implant may be slightly different than the position of the actual implant in the patient's mouth. Customers are instructed to: Product in the scope of this recall should be discarded or returned to PREAT CORPORATION. For questions contact Quality Regulatory Affairs at 224-622-7191 or email jespino@younginnovations.com

Root cause

Process control

Status

Open, Classified

Product code

NDP

Quantity affected

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

Date initiated

2024-06-25

Date posted

2024-08-19

Location

Santa Maria, CA