stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s
Summary
The FDA issued a Class II for stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM00 by Tornier, Inc. Reason: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device)..
Details
Source
Device Recall
External ID
Z-3155-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Lot/Code Info: UDI/DI 00846832092192, Lot number 3268BA
Quantity Affected: 5 units
Reason for Recall
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Distribution
US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-29
Company
Bloomington, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier, Inc have FDA actions?
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3155-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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