The Recall Desk
SevereFDA (Devices)·Z-0290-2019·Announced 2018-11-07

Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

Stryker GmbH is recalling 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.

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 involves a structural defect in a medical device that compromises stability, which aligns with the rubric criteria for a 'Severe' rating (structural defect/significant injury risk).

Plain-English summary

Stryker GmbH is recalling 1,355 units of the Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm (Model Number 4935-0-030). The recall covers specific lots distributed nationwide in Colorado, Florida, Maryland, Michigan, New York, Oklahoma, and Pennsylvania.

The recall was initiated because 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 result in a reduced press fit of the pin. This defect can lead to partial or full displacement or loss of the pin, meaning the stability of the strut and the frame cannot be ensured.

The product is indicated for the treatment and fixation of various fractures and deformities in pediatric patients and adults. Because the defect poses a risk to the structural integrity of the medical device, affected patients and healthcare providers should contact Stryker GmbH for instructions on how to proceed.

The recalled product

Product
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. 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
1,355

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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