Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking
A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall involving a surgical implant where incorrect marking and color indicators create risk of harm through surgical error (implanting wrong device size/orientation). No illnesses or injuries have been reported in the source text, placing this at the High severity level per the rubric.
Plain-English summary
Tornier, Inc. is recalling a specific lot of Stryker Latitude EV Humeral Revision Stem Trial devices due to incorrect direct part marking. The devices are laser marked as REF 9030103 (Humeral Stem Trial 150mm Large / Right with yellow color indicator), but the devices actually contain REF 9030092 (Humeral Stem Trial 150mm Medium / Left with red color indicator).
This marking discrepancy creates a risk that the wrong device size and orientation may be implanted during surgical procedures. The affected units include batch number CC0421265 (GTIN 00846832015054), with 5 units distributed internationally to Sweden, Australia, United Kingdom, Colombia, and Germany.
Healthcare facilities and physicians in affected countries that received this lot should immediately verify inventory and quarantine the affected devices to prevent potential surgical errors. Contact Tornier, Inc. for return or replacement instructions.
The recalled product
- Product
- stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
- Manufacturer
- Tornier, Inc
- Hazard
- mis-labeling
- surgical-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00846832015054
- Batch Number CC0421265
Distribution
Distribution scope not specified by the agency.
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