Tornier Inc

Reports per year

Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Shoulder Prosthesis, Reverse ConfigurationPHX999
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS971
• Prosthesis, Elbow, Semi-Constrained, CementedJDB352
• Bit, SurgicalGFG137
• Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD135
• Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedPKC92
• Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedPAO90
• ImpactorHWA84
• Rod, Fixation, Intramedullary And AccessoriesHSB48
• ScrewdriverHXX46

Recent recalls

• 2026-04-03Open, ClassifiedLabeling design

  Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

  Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

• 2026-02-02Open, ClassifiedLabeling mix-ups

  TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

  A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

• 2025-04-22Open, ClassifiedUnder Investigation by firm

  stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

  A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

• 2024-09-27Open, ClassifiedUnder Investigation by firm

  Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

  Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

• 2024-09-16Open, ClassifiedUnder Investigation by firm

  stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

  One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

• 2024-01-19Open, ClassifiedPackaging process control

  Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

  The incorrect device is contained in the labeled package.

• 2023-10-13Open, ClassifiedProcess change control

  stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

  One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

• 2023-06-28Open, ClassifiedUnder Investigation by firm

  AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

  A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

• 2023-06-28Open, ClassifiedUnder Investigation by firm

  AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

  A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

• 2015-08-26TerminatedNonconforming Material/Component

  Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

  Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.