Tornier, Inc: Device Recall

Recall Details

Recall Number

Z-1651-2025

Classification

Class II

Product Type

Device

Recalling Firm

Tornier, Inc

Status

Ongoing

Date Initiated

03/03/2025

Location

Bloomington, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

5 units

Reason for Recall

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)

Product Description

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

Distribution Pattern

OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany

Other Recalls by Tornier, Inc

• Class II: Risk 12/19/2025
  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.
• Class II: Risk 08/29/2024
  One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
• Class II: Risk 08/29/2024
  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.

View all recalls by Tornier, Inc →