CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report

stryker Latitude EV Humeral Revision Stem Trial, L:, Size recalled

Tornier is recalling stryker Latitude EV Humeral Revision Stem Trial, L:, Size: Large, Side: Right, distributed nationwide in the US. The recall was initiated on 3 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 00846832015054, Batch Number CC0421265

Quantity recalled5 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1651-2025
FDA event ID: 96494
Recalling firm: Tornier, Bloomington, MN
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2025
FDA classified: 22 Apr 2025
Reported: 30 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Mar 2025	Recall initiated by company
22 Apr 2025	Classified by FDA	+50 days
30 Apr 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 00846832015054, Batch Number CC0421265

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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