FDA Medical devices recall ·
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE… recall
- Recall number
- Z-1651-2025
- Date
- (initiated March 3, 2025)
- Company / brand
- Tornier, Inc
10801 Nesbitt Ave S, Bloomington, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Why was it recalled?
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)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00846832015054, Batch Number CC0421265
Distribution
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1651-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.