Stryker recalls Hoffman LRF Hexapod Strut model 4935-0-010 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 with model number 4935-0-010 because a manufacturing defect could cause the pin to become loose, leading to loss of stability in the medical device. This risk affects patients using the device for fracture treatment or limb lengthening procedures.
The press fit connection between the Angular Sleeve and pin may be too loose due to a manufacturing defect. This can cause the pin to partially or fully displace, which compromises the strut's stability and could lead to improper treatment outcomes.
Patients using the Hoffman LRF Hexapod Strut for fracture treatment, limb lengthening, or joint reconstruction are most at risk. The device is used in pediatric and adult patients.
Check for model number 4935-0-010 on the Hoffman LRF Hexapod Strut. The product was sold in specific lots from 2016: L13687, L22247, L18236, L25182, L31085, L35845, L47079, L47736, L57503, Y00078, Y03126, Y07637, Y07634, Y11976, Y14639, Y14643, Y18430.
Look for model number 4935-0-010 on the Hoffman LRF Hexapod Strut.
Reach out to Stryker for guidance on next steps if you have the recalled model.
The press fit connection between the Angular Sleeve and pin may be too loose due to a manufacturing defect, which can cause the pin to become displaced and compromise the strut's stability.
The recalled product is model number 4935-0-010.
Affected lots include L13687, L22247, L18236, L25182, L31085, L35845, L47079, L47736, L57503, Y00078, Y03126, Y07637, Y07634, Y11976, Y14639, Y14643, Y18430.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0288-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0288-2019 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.
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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.
