Recall Z-3155-2024— Tornier, Inc
Class II · Ongoing
Class II FDA medical device recall by Tornier, Inc, initiated 2024-08-29. It names one FDA 510(k) clearance: K220418. 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)..
- Recalling firm
- Tornier, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-29
- Firm location
- Bloomington, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.