Recall Z-0744-2025 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Limacorporate S.p.A
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
| Date | Dec 20, 2024 (initiated Oct 2, 2024) |
| Status | Open, Classified |
| Reason | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. |
| Root cause | Process control |
| Action | On 10/02/2024, the firm notified U.S. surgeons of the recall and the two U.S. distributors were informed via email on 10/11/2024. An updated/follow-up Recall Notification and Acknowledgement form is pending. The update/follow-up Recall Notification is informing surgeons and distributors that the firm has received a total of two similar complaints, regarding issues related to difficulty in disassembly of the axle component by using the screwdriver as per Surgical Technique. According to the internal investigation, the main concurring root causes of the problem seem to be the incomplete shot p |
| Quantity | ~87 devices (U.S.) |
| Distribution | U.S: FL and TX O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222807 | TEMA Elbow system - Line extension Lima Corporate S.P.A., Oct 26, 2022 |