FDA WARNING_LETTER - Synovo Production, Inc. - October 26, 2022

On March 23, 2023, the FDA issued a Warning Letter to Synovo Production, Inc. following an inspection from October 11-26, 2022. The inspection revealed significant violations regarding their "Femoral Resurfacing Cup" and "Total Hip System" devices.

The Femoral Resurfacing Cup, cleared in 1991 for cemented use, was found to have undergone significant design and manufacturing changes, including a new coating for cementless fixation, without a new 510(k) submission. This renders the device misbranded under 21 U.S.C. § 352(o) and adulterated under 21 U.S.C. § 351(f)(1)(B) due to lack of an approved PMA or IDE.

The "Total Hip System," which includes the Femoral Resurfacing Cup, is classified as a Class III device requiring PMA approval. Synovo was found to be marketing this system without an approved PMA or IDE, making it adulterated and misbranded.

Additionally, the inspection revealed multiple Quality System regulation violations (21 CFR Part 820), including: 1. Failure to validate process changes (e.g., coating change to Titanium Plasma Spray, discontinuation of a machining process) (21 CFR 820.75(a)). 2. Failure to control