Memphis, TN, United States
Medacta Usa Inc recalls
6 recalls recorded since 2018, most recently on 30 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
- Distribution
- US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2618-2026
- Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10
Completed Class II Medical devices
- Recall started
- 8 March 2023
- Reason
- There is a potential for breakage of the small screw used to affix the anti-backout plate.
- Distribution
- US: ID, TX, GA, VA, AZ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1400-2023, Z-1402-2023, Z-1405-2023, Z-1404-2023, Z-1401-2023, Z-1403-2023
- MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
- MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
- MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
- MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
- MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
- MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Terminated Class II Medical devices
- Recall started
- 27 October 2022
- Terminated
- 23 October 2023
- Reason
- A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
- Distribution
- AL, FL, NH, CO, IL, SC, AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0372-2023
- NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Terminated Class II Medical devices
- Recall started
- 13 April 2022
- Terminated
- 23 October 2023
- Reason
- A Size 2 trial baseplate was assembled with Size 1 instrument sets.
- Distribution
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1247-2022
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Terminated Class II Medical devices
- Recall started
- 4 November 2019
- Terminated
- 21 May 2021
- Reason
- Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
- Distribution
- US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0775-2020
- Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primar
Terminated Class II Medical devices
- Recall started
- 15 November 2017
- Terminated
- 29 March 2019
- Reason
- Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
- Distribution
- NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0196-2019
- Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.