Z-3155-2024 Class II Ongoing
FDA device recall Z-3155-2024 was initiated by Tornier, Inc on August 29, 2024 and is designated Class II. Reason for recall: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- August 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Reason for Recall
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Distribution Pattern
US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Code Information
UDI/DI 00846832092192, Lot number 3268BA