Facility

ALTO DEVELOPMENT CORP.

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

Key facts

3recalls · worst Class II

1inspections · worst VAI

—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)	2242056
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	5206 Asbury Road FARMINGDALE, NJ, US 07727
Registration status	Active · expires 2026
Parent company	ALTO DEVELOPMENT CORP. (owner-operator 2242056)
Brand names	Sternalock® XP Rigid Fixation System

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (4)

Plate, Fixation, Bone
Product code HRS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Product code GAQ (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4495
Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
Cerclage, Fixation
Product code JDQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3010

Recalls & enforcement

Class IITerminated2019-09-10
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
Class IITerminated2019-06-21
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
Class IITerminated2017-10-23
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

FDA inspections (1)

VAI2018-06-28
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ALTO DEVELOPMENT CORP.

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. “ALTO DEVELOPMENT CORP. (FEI 2242056) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2242056-alto-development-corp/

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