Facility

MEDSHAPE, INC.

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

Key facts

2recalls · 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)	3007593722
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	1575 NORTHSIDE DR NW STE 440 Atlanta, GA, US 30318
Registration status	Active · expires 2026
Parent company	MedShape, Incorporated (owner-operator 10026693)
Brand names	EF1 External Fixation System Wrench

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Wrench
Product code HXC (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2025-06-02
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Class IIOngoing2021-11-17
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.

FDA inspections (2)

NAI2026-02-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-04-16
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 MedShape, Incorporated

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. “MEDSHAPE, INC. (FEI 3007593722) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007593722-medshape-inc/

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