Recall Z-1651-2025 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Tornier, Inc
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
| Date | Apr 22, 2025 (initiated Mar 3, 2025) |
| Status | Open, Classified |
| Reason | 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) |
| 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 |
| Quantity | 5 units |
| Distribution | OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100562 | LATITUDE ELBOW PROSTHESIS Tornier, Inc., Jun 29, 2010 |