Facility

Align Technology AFAB Poland Sp. z o.o.

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

Key facts

1recalls · 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)	3025237243
Establishment type	Manufacture Medical Device
Location	Bierutowska 44 Street Wroclaw Dolnoslaskie, PL 51317
Registration status	Active · expires 2026
Parent company	Align Technology, Inc. (owner-operator 9035576)
Brand names	Vivera Retainer; Vivera 3D retainer; Invisalign Retainer

Activity by year

Recalls (1)

Devices registered here (1)

Maintainer, Space Preformed, Orthodontic
Product code DYT (opens in a new tab) · Class I · Dental · 21 CFR 872.5525

Recalls & enforcement

Class IICompleted2022-12-05
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.

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. “Align Technology AFAB Poland Sp. z o.o. (FEI 3025237243) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3025237243-align-technology-afab-poland-sp-z-o-o/

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