Reported Apr 30, 2025 · Ongoing
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow,…
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
- stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm
- SizeLARGE
- SideRIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
- Lot codes and dates
GTIN 00846832015054Batch Number CC0421265
- Amount recalled
- 5 units
Why it was 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)
This product could cause temporary or reversible health problems — stop using it.
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