Medacta Usa recalls

Medacta Usa appears in 20 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• 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.…
  FDA Device · Class II · 2026-07-08 · Medacta Usa
  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 mor…
• MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
  FDA Device · Class II · 2023-04-26 · Medacta Usa
  Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate.
• NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a…
  FDA Device · Class II · 2022-12-14 · Medacta Usa
  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 adeq…
• GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
  FDA Device · Class II · 2022-06-15 · Medacta Usa
  Reason: A Size 2 trial baseplate was assembled with Size 1 instrument sets.
• Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic S…
  FDA Device · Class II · 2020-01-15 · Medacta Usa
  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.
• Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revi…
  FDA Device · Class II · 2018-10-31 · Medacta Usa
  Reason: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
• The GMK knee system: designed for cemented use in total knee arthroplasty
  FDA Device · Class II · 2017-12-27 · Medacta Usa
  Reason: Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used,…
• Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
  FDA Device · Class II · 2017-07-12 · Medacta Usa
  Reason: One lot of product does not include a screw for attachment to the tibial base plate.
• 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 be…
  FDA Device · Class II · 2017-01-25 · Medacta Usa
  Reason: Damaged packaging, lack of sterility assurance
• GMK Hinge knee prosthesis
  FDA Device · Class II · 2015-11-25 · Medacta Usa
  Reason: Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
• The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants
  FDA Device · Class II · 2014-11-26 · Medacta Usa
  Reason: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
• GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement
  FDA Device · Class II · 2014-11-19 · Medacta Usa
  Reason: Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
• 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), 01.26.10.0…
  FDA Device · Class II · 2013-03-06 · Medacta Usa
  Reason: Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications un…
• Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System
  FDA Device · Class II · 2013-02-13 · Medacta Usa
  Reason: The tip of the Quadra Trial Broach size 0, broke during a surgery.
• Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the…
  FDA Device · Class II · 2012-11-14 · Medacta Usa
  Reason: Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to loc…