The Recall Desk
SevereFDA (Devices)·Z-0291-2019·Announced 2018-11-07

Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to loss of stability, meeting the criteria for a Severe rating.

Plain-English summary

Stryker GmbH is recalling 867 units of the Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. The affected devices were distributed nationwide in Colorado, Florida, Maryland, Michigan, New York, Oklahoma, and Pennsylvania. The recall involves specific lot numbers, including L18239, L13690, and Y02173.

The recall is due to a manufacturing defect where the press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy in the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial or full displacement or loss of the pin, meaning the stability of the strut of the frame cannot be ensured.

The Hoffman LRF System is indicated for the treatment and fixation of various fractures and deformities in pediatric patients and adults. Because the defect may compromise the structural stability of the device, patients and healthcare providers should contact Stryker GmbH for further instructions on how to proceed.

The recalled product

Product
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Fixation
Hazard
Affected units
867

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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