stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se
Summary
The FDA issued a Class II for stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: R by Tornier, Inc. Reason: A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right.
Details
Source
Device Recall
External ID
Z-1651-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Lot/Code Info: GTIN 00846832015054, Batch Number CC0421265
Quantity Affected: 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)
Distribution
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-03
Company
Bloomington, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier, Inc have FDA actions?
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1651-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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