The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0289-2019·Announced 2018-11-07

Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 an orthopedic implant that could lead to loss of frame stability, meeting the criteria for a Severe rating.

Plain-English summary

Stryker GmbH is recalling 832 units of the Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm (Model Number 4935-0-020). These medical devices are indicated for the treatment and fixation of various fractures, joint contractures, and bone deformities in pediatric patients and adults. The affected units were distributed nationwide in Colorado, Florida, Maryland, Michigan, New York, Oklahoma, and Pennsylvania.

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 result in a reduced press fit of the pin. This defect can cause partial or full displacement or loss of the pin, meaning the stability of the strut and the frame cannot be ensured.

Healthcare providers and patients should identify affected units by checking the lot numbers listed in the official recall notice. If a patient has an affected device implanted, they should contact their healthcare provider to discuss the potential risks and necessary follow-up care.

The recalled product

Product
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. 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 Implant
Hazard
Affected units
832

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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