Device product
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Z-3155-2024
Product summary
- Firm
- Tornier, Inc
- Event
- Event 95258
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-3155-2024
Official wording
Reason: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Code information: UDI/DI 00846832092192, Lot number 3268BA
Distribution pattern: US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Derived failure modes
-
Unknown
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).