Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Summary
The FDA issued a Class II for Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; by Stryker GmbH. Reason: The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery..
Details
Source
Device Recall
External ID
Z-1621-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
Product Description
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Lot/Code Info: Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: KU164143, KU164755, KU164756, KU164757, KU164758, KU164759, KU164760, KU164761, KU164762, KU164763, KU164764, KU164765, KU164766, KU164767, KU164768, KU164769, KU164770, KU164771, KU164772, KU164773, KU164774, KU164775, KU164776, KU164777, KU164778, KU164779, KU164780, KU164781, KU164782, KU164783, KU164784, KU165161, KU165162, KU165163, KU165164, KU165165, KU165166, KU165167, KU165168, KU165169, KU165170, KU165171, KU165172, KU165173, KU165174, KU165175, KU184035, KU184036, KU184039, KU184041, KU184042, KU184044, KU184045, KU184046, KU184047, KU184049.
Quantity Affected: 6407 units
Reason for Recall
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Distribution
US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-28
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 165 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-1621-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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