FDAClass IIJuly 3, 2024

Stryker Hoffman LRF Wire Tensioner recall

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Why was Stryker Hoffman LRF Wire Tensioner recalled?

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #J43995, UDI-DI 07613252611035.

Product
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Recalling firm
Stryker GmbH
Quantity
39 devices
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.
Recall date
July 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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