FDA Device recall Z-3155-2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A by Tornier, citing one lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3155-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-29 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tornier |
| Distribution | US |
Product
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Reason
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Identifiers
| code_info | UDI/DI 00846832092192, Lot number 3268BA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3155-2024%22
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