Tornier Latitude recallZ-1651-2025 · Tornier, Inc · initiated Mar 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tornier, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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)
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 03/03/2025 via Trackwise (email). The notice explained the issue, potential risk, and requested the following: "1. Immediately check your internal inventory to locate the product listed on the attached business reply form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Return the enclosed business reply form by email to confirm receipt of this notification/document product segregation. a. Response is required, even if you may not have any physical inventory on site anymore. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. 6. Please inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with current regulations. For questions or concerns, please contact [email protected]."
Recall details
- Recall number
- Z-1651-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 3, 2025
- Posted by the FDA
- Apr 22, 2025
- Recalling firm
- Tornier, Inc
- Quantity
- 5 units
- Product code
- JDB
- FDA submissions
- K100562
- Distribution
- OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Product description
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Code information (models, lots, serial numbers)
GTIN 00846832015054, Batch Number CC0421265
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tornier Latitude 9030103Tornier, Inc. · Orthopedic manual surgical instrument1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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