Facility

Extremity Medical, LLC

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

Key facts

4recalls · worst Class II

2inspections · worst NAI

—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)	3007289093
Establishment type	Manufacture Device in the United States for Export Only
Location	300 Interpace Pkwy Parsippany, NJ, US 07054
Registration status	Active · expires 2026
Parent company	Extremity Medical, LLC (owner-operator 10027988)
Brand names	KinematX

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Prosthesis, Wrist, Semi-Constrained
Product code KWM (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3800

Recalls & enforcement

Class IITerminated2013-01-10
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Class IITerminated2012-03-22
Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Class IITerminated2011-04-25
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
Class IITerminated2011-04-13
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

FDA inspections (2)

NAI2026-06-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-05-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 Extremity Medical, LLC

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. “Extremity Medical, LLC (FEI 3007289093) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007289093-extremity-medical-llc/

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