Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Summary
The FDA issued a Class II for Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ00 by Tornier, Inc. Reason: The incorrect device is contained in the labeled package..
Details
Source
Device Recall
External ID
Z-0773-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Lot/Code Info: Batch lot codes 6714AZ, serial numbers 001 to 050: 6714AZ001, 6714AZ002, 6714AZ003, 6714AZ004, 6714AZ005, 6714AZ006, 6714AZ007, 6714AZ008, 6714AZ009, 6714AZ010, 6714AZ011, 6714AZ012, 6714AZ013, 6714AZ014, 6714AZ015, 6714AZ016, 6714AZ017, 6714AZ018, 6714AZ019, 6714AZ020, 6714AZ021, 6714AZ022, 6714AZ023, 6714AZ024, 6714AZ025, 6714AZ026, 6714AZ027, 6714AZ028, 6714AZ029, 6714AZ030, 6714AZ031, 6714AZ032, 6714AZ033, 6714AZ034, 6714AZ035, 6714AZ036, 6714AZ037, 6714AZ038, 6714AZ039, 6714AZ040, 6714AZ041, 6714AZ042, 6714AZ043, 6714AZ044, 6714AZ045, 6714AZ046, 6714AZ047, 6714AZ048, 6714AZ049, 6714AZ050; GTIN 00846832091614.
Quantity Affected: 50
Reason for Recall
The incorrect device is contained in the labeled package.
Distribution
Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-03
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 144 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-0773-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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