The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0288-2019·Announced 2018-11-07

Stryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect

Stryker GmbH is recalling 578 Hoffmann 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 involves a structural defect in a medical device that compromises the stability of the frame, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury risk in a high-risk product context.

Plain-English summary

Stryker GmbH is recalling 578 units of the Hoffmann LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. The affected devices are indicated for the treatment and fixation of various fractures and deformities in pediatric patients and adults. The recall covers specific lots distributed 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 cause a reduced press fit of the pin. This defect can result in the 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 contact Stryker GmbH for instructions on how to manage the affected devices. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. 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
578

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 →

Related recalls

Same manufacturer · Stryker GmbH

See all →

Same hazard · structural defect

See all →

Similar recalls