Tornier, Inc: Medical Device Recall in 2025 - (Recall #: Z-1651-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 3, 2025

Date Posted: April 30, 2025

Recall Number: Z-1651-2025

Event ID: 96494

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)

Status: Ongoing

Product Quantity: 5 units

Code Information:

GTIN 00846832015054, Batch Number CC0421265

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated