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Recall Observatory FDA recall evidence

Device product

Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Z-1621-2025

March 28, 2025

Class II

Product summary

Firm
Stryker GmbH
Event
Event 96555
Status
Ongoing
Classification
Class II
Quantity
6407 units
Official record key
device-enforcement:Z-1621-2025

Official wording

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.

Code information: 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.

Distribution pattern: US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.