stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US recall: Endotoxin
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Why was stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US recalled?
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00846832092192, Lot number 3268BA
- Product
- stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
- Recalling firm
- Tornier, Inc
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)