Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Summary
The FDA issued a Class II for Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog by Stryker GmbH. Reason: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail..
Details
Source
Device Recall
External ID
Z-1914-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Lot/Code Info: Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Reason for Recall
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-28
Company
Selzach
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 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 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 (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1914-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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