RegWardenFDA facility compliance records
Facility

Xtremity by WillowWood Global

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

Activity by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

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.

Related

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. “Xtremity by WillowWood Global (FEI 3038873185) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3038873185-xtremity-by-willowwood-global/

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