Agency classClass IIOur severity:Severe FDA (Devices)·Z-2444-2018·Announced 2018-07-25

NewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk

NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of deep infection requiring intravenous antibiotics and device removal, which aligns with the rubric criteria for Severe severity involving significant injury or hospitalization-level medical intervention.

Plain-English summary

NewDeal SA is recalling specific model numbers of the ADVANSYS TTC medical device. The affected models include 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S, and 181004S. The recall covers specific lot numbers for each model, which are detailed in the agency's official records.

The recall was initiated because the use of the impacted product may cause a superficial infection requiring oral antibiotics and wound care, or a deep infection requiring intravenous antibiotics and device removal. The devices were distributed in California, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington, and Wisconsin.

Healthcare providers and patients should stop using the affected devices and contact NewDeal SA for instructions on how to proceed. The U.S. Food and Drug Administration has classified this as a Class II recall.

The recalled product

Product: ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
Manufacturer: NewDeal SA
Category: Medical Device — Implantable Device
Hazard: infection

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 (17)

181011S - Lot # E8PF/G
F5CE 181012S - Lot # E8MB/G
E8MV/G & E8PG/G1 181013S - Lot # E8MC/G
E8MW/G
E8NF/G
E8NF/G1
E8NZ/G
E8PH/G
F538
F5CG & F7G7 181014S - Lot # E8MD/G
E8NG/G
E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G
E8MR/G & E8PC/G 181003S - Lot # E8MS/G
E8NB/G
E8NV/G
F537 & F5CC 181004S - Lot # E8MD/G
E8P0/G & E8PJ/1

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 5 recalled by NewDeal SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · NewDeal SA

See all →

Severe
NewDeal UNI-CP Medical Devices Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
High
NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
Severe
NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk
FDA (Devices) · 2018-07-25
High
NewDeal Large QWIX Medical Device Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25

Same hazard · infection