Manufacturer

Medacta Usa Inc

17 recalls in our database name Medacta Usa Inc as the manufacturing or recalling firm.

What the numbers show

Total: 17
Critical: 0
Severe: 0
Most recent: 2026-07-08

Of the 17 recalls from Medacta Usa Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

HighFDA (Devices)·Z-2618-2026·2026-07-08
Medacta Short Monobloc Stem Broaches Surgical Instruments Shoulder Implant
Medacta USA is recalling Short Monobloc Stem Broaches used in shoulder replacement surgery due to positioning misalignment that may increase risk of fracture in the upper arm bone.
Product
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, 16/04.01.10.0979 Part of Medacta Shoulder System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2023·2023-04-26
Spinal fusion device antibackout screw may break, FDA recalls
Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.
Product
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1403-2023·2023-04-26
FDA Recalls MectaLIF ANTERIOR Interbody Fusion Device Due to Screw Breakage Risk
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United States.
Product
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1401-2023·2023-04-26
Medacta interbody fusion plate device recalled for screw breakage
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device because the small screw affixing the anti-backout plate may break, potentially compromising device integrity.
Product
MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1402-2023·2023-04-26
Medacta MectaLIF ANTERIOR spine implant recalled due to screw breakage risk
Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five US states.
Product
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1404-2023·2023-04-26
Interbody Fusion Device Recalled for Potential Screw Breakage
Medacta's MectaLIF ANTERIOR fusion device is being recalled due to potential breakage of a small screw used to affix the anti-backout plate. The recall affects 17 units distributed across the US.
Product
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1400-2023·2023-04-26
FDA Recalls MectaLIF ANTERIOR Spinal Fusion Device Due to Screw Breakage Risk
Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H10 interbody fusion device due to a potential risk of screw breakage in the anti-backout plate. No injuries have been reported.
Product
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0372-2023·2022-12-14
Shoulder Surgical Navigation System Warning for Bone Stability
A warning has been added to the NextAR Shoulder surgical navigation platform advising verification of adequate coracoid bone stability. Inadequate stability could lead to bone fracture during reverse shoulder surgery.
Product
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
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1247-2022·2022-06-15
GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall
Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.
Product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0775-2020·2020-01-15
Medacta Shoulder Implant Recall Due to Screw Insertion Limitation
Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.
Product
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 primary or revision total shoulder replacement in patients with an
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0196-2019·2018-10-31
Medacta MiniMAX Cementless Hip Stem Recalled for Packaging Breach
Medacta USA Inc. is recalling 837 units of MiniMAX Cementless Anatomical Stems because complaint monitoring identified a trend of packaging breaches.
Product
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0266-2018·2017-12-27
Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk
Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.
Product
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2661-2017·2017-07-12
Medacta GMK Hinge Tibial Insert Recalled for Missing Attachment Screw
Medacta USA Inc. is recalling one lot of GMK Hinge Tibial Inserts because they are missing a screw required for attachment to the tibial base plate.
Product
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1023-2017·2017-01-25
Medacta M.U.S.T. Rods Recalled for Damaged Packaging and Sterility Issues
Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.
Product
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2013·2013-03-06
Medacta Recalls Versafitcup Impacting Rings for Fit Issues
Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.
Product
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0791-2013·2013-02-13
Medacta Quadra Trial Broach size 0 recalled due to tip breakage
Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.
Product
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2013·2012-11-14
Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk
Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.
Product
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Category
Medical Device
Distribution
3 states