stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Reported: September 25, 2024 Initiated: August 29, 2024 #Z-3155-2024
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).
Details
- Recalling Firm
- Tornier, Inc
- Units Affected
- 5 units
- Distribution
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Location
- Bloomington, MN
Frequently Asked Questions
What product was recalled? ▼
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder. Recalled by Tornier, Inc. Units affected: 5 units.
Why was this product recalled? ▼
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3155-2024.
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