Stryker Latitude EV Humeral Stem Trial recalled for incorrect marking
A Stryker Latitude EV Humeral Stem Trial is recalled because the laser marking specifies incorrect specifications—150mm Large / Right instead of the actual 150mm Medium / Left, which could lead to wrong prosthesis implantation.
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: FDA Class II recall of mislabeled surgical prostheses. While no injuries or deaths have been reported, the incorrect marking poses direct risk of wrong-size, wrong-side prosthesis implantation during surgery, which could compromise patient outcomes.
Plain-English summary
The Stryker Latitude EV Humeral Revision Stem Trial (Batch CC0421265, GTIN 00846832015054) is being recalled. This is a semi-constrained cemented elbow prosthesis used in revision surgeries. A specific lot contains devices with incorrect laser marking that does not match the actual product specifications.
The affected devices are laser marked as '9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator,' but they actually contain the specifications for a different product: '9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator.' The marking indicates incorrect size and side specifications compared to the actual device.
Approximately 5 units were distributed internationally to Sweden, Australia, United Kingdom, Colombia, and Germany. If surgical teams rely on the laser marking during implantation, they may select and implant a prosthesis of the wrong size and wrong side, potentially compromising surgical outcomes and patient safety.
Healthcare facilities that received this product should immediately verify actual device specifications against the marking. Facilities should review all cases where this batch was used to confirm the correct prosthesis was implanted. Contact Tornier, Inc for guidance on return and replacement.
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
- mislabeling
- prosthesis-mismatch
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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