Facility

WillowWood Global LLC

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

Key facts

1recalls · worst Class II

2inspections · 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)	1522166
Establishment type	Manufacture Medical Device
Location	15441 SCIOTO DARBY RD. Mt Sterling, OH, US 43143
Registration status	Active · expires 2026
Parent company	WillowWood Global LLC (owner-operator 1522166)
Brand names	Xtremity Custom Sockets

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Prosthesis, Thigh Socket, External Component
Product code ISS (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3420

Recalls & enforcement

Class IIOngoing2021-04-20
the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.

FDA inspections (2)

NAI2025-02-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-01-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

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. “WillowWood Global LLC (FEI 1522166) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1522166-willowwood-global-llc/

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