Facility

Ormex S. de R.L. de C.V.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002807826
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	CALLE 21, No. 1103, AMPLIACION YUCATAN UMAN, MX 97390
Registration status	Active · expires 2026
Parent company	SYBRON DENTAL SPECIALTIES, INC. (owner-operator 9029565)

Activity by year

Recalls (2)

Devices registered here (1)

Bracket, Metal, Orthodontic
Product code EJF (opens in a new tab) · Class I · Dental · 21 CFR 872.5410

Recalls & enforcement

Class IITerminated2015-02-11
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
Class IITerminated2013-06-06
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Ormex S. de R.L. de C.V. (FEI 3002807826) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807826-ormex-s-de-r-l-de-c-v/

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