Facility

Tyber Medical

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)	3012966183
Establishment type	Repack or Relabel Medical Device
Location	83 South Commerce Way Bethlehem, PA, US 18017
Registration status	Active · expires 2026
Parent company	Tyber Medical LLC (owner-operator 10046574)
Brand names	Wire System

Activity by year

Recalls (2)

Devices registered here (1)

Pin, Fixation, Smooth
Product code HTY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IIOngoing2025-12-19
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Class IIOngoing2025-01-21
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

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. “Tyber Medical (FEI 3012966183) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012966183-tyber-medical/

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