Stryker recalls Hoffman LRF Hexapod Struts (Model 4935-0-020) due to potential pin displacement causing instability. Affected units sold in specific lots from 2016.
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
Stryker is recalling Hoffman LRF Hexapod Struts (Model 4935-0-020) because a manufacturing defect may cause the pin to become loose, risking the strut's stability. This could lead to improper fracture treatment or injury if the device fails during use.
The strut's pin may become loose due to a dimensional discrepancy in the Angular Sleeve, which can cause partial or complete displacement of the pin. This compromises the strut's stability, potentially leading to improper fracture alignment or treatment failure.
Patients using the Hoffman LRF Hexapod Strut for bone fractures, joint issues, or limb lengthening procedures are most at risk. The recall affects specific model numbers and production lots sold between 2016 and present.
Check for the model number 4935-0-020 on the strut. The product was sold in specific lots (L18237, L13688, etc.) between 2016 and present for pediatric and adult patients needing bone fracture treatment.
Identify the model number and lot numbers listed in the recall notice to confirm if your device is affected.
The recall is due to a manufacturing defect where the pin may become loose, risking the strut's stability during use.
The recall does not specify a remedy, so contact Stryker directly to determine if your device needs replacement or adjustment.
Patients using the Hoffman LRF Hexapod Strut for bone fractures, joint issues, or limb lengthening procedures are most at risk.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0289-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0289-2019 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
