stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Summary
The FDA issued a Class II for stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, by Tornier, Inc. Reason: One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconf.
Details
Source
Device Recall
External ID
Z-0113-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
Product Description
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Lot/Code Info: UDI/DI 10846832062017, Lot Number 1756123
Quantity Affected: 30 units
Reason for Recall
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
Distribution
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-15
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 141 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-0113-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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