Z-1651-2025Class II

stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis...

Name: Z-1651-2025 stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis...
Creator: Tornier, Inc
Published: 2025-03-03
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2025-03-03 / Open, Classified

FDA source

Tornier, Inc began a recall of stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented on 2025-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1651-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-03
Posted: 2025-04-22
Recalling firm: TORNIER Inc.
Product: stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Product code: JDB Prosthesis, Elbow, Semi-Constrained, Cemented
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)
FDA root cause: Under Investigation by firm
Action: 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]."
Quantity in commerce: 5 units
Distribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Product codes and lots: GTIN 00846832015054, Batch Number CC0421265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1651-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1651-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22

Product code JDB

K100562Class IILatitude Elbow ProsthesisTornier, Inc. / cleared 2010-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)