FDA Enforcement
Class II
Ongoing
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Recall: Z-3155-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3155-2024
- Event ID
- 95258
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tornier, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 25, 2024
- Initiation Date
- August 29, 2024
- Classification Date
- September 16, 2024
- Address
- 10801 Nesbitt Ave S, Bloomington, MN, 55437-3109, United States
Description
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).
Code Info
UDI/DI 00846832092192, Lot number 3268BA
Distribution
US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Quantity
5 units