Guide Wire with Ruler Tube 3x800 mm Metal Ring Detachment Recall
Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a defect that could cause intraoperative complications (metal ring detachment during surgery). The source text does not report any injuries or illnesses, making this a risk-of-harm scenario without reported adverse events, consistent with a High severity classification per the rubric.
Plain-English summary
Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA (Catalog number/REF: 2351-3080S) because the metal ring at the end of the instrument may detach from the main body during use in surgery. A total of 1,588 units have been distributed nationwide.
The recalled products were distributed across California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas, and West Virginia. The affected lot numbers are KU155697 through KU155712. Affected devices can be identified by the UDI-DI: 07613327361797.
Healthcare facilities and providers who have this device in stock should stop using it immediately and contact Stryker GmbH for instructions on returning or replacing affected units.
The recalled product
- Product
- Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
- Manufacturer
- Stryker GmbH
- Hazard
- metal-detachment
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Catalog number/REF: 2351-3080S
- UDI-DI: 07613327361797
- Lot #: KU155697
- KU155698
- KU155699
- KU155700
- KU155701
- KU155702
- KU155703
- KU155704
- KU155705
- KU155706
- KU155707
- KU155708
- KU155709
- KU155710
- KU155711
- KU155712.
Distribution
Distributed nationwide across the United States.
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