stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
- Company
- Tornier, Inc
- Recall Initiated
- March 3, 2025
- Posted
- April 22, 2025
- Recall Number
- Z-1651-2025
- Quantity
- 5 units
- Firm Location
- Bloomington, MN
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)
Distribution
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Lot / Code Info
GTIN 00846832015054, Batch Number CC0421265
Root Cause
Under Investigation by firm
Action Taken
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 memphis.fieldaction@stryker.com."