← Every firm
Tornier, Inc FDA Recalls
11 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Class IIMar 5, 2026Affected products were incorrectly labeled as Tornier HRS Ma |
| TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318Class IIDec 19, 2025A specific lot of screws is incorrectly labeled. Screws are |
| stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, SeClass IIMar 3, 2025A specific lot of Latitude Humeral Trial Stems has the incor |
| Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplastyClass IIAug 29, 2024Devices from one lot of Perform" Reversed Inserts may contai |
| stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the sClass IIAug 29, 2024One lot of Perform Humeral Nucleus may exceed the specificat |
| Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.Class IIJan 3, 2024The incorrect device is contained in the labeled package. |
| stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502Class IISep 15, 2023One lot of Tournier Perform Reversed Lateralized Baseplates |
| AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101Class IIJun 12, 2023A comingle/swap resulted in the labeling and laser marking o |
| AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118Class IIJun 12, 2023A comingle/swap resulted in the labeling and laser marking o |
| Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kitClass IIMay 3, 2022The device is unable to meet sterilization requirements when |
| Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier Class IIMay 28, 2021Two lots have been swapped thus have the incorrect product i |