Stryker recalls Hoffman LRF Hexapod Struts with model 4935-0-040 due to potential pin displacement causing instability. Affected units sold in specific lots; contact Stryker for remedy.
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 4935-0-040) because a manufacturing defect may cause the pin to become loose, leading to loss of stability. This could result in improper treatment of fractures or other medical conditions if the device fails during use.
The press fit connection between the Angular Sleeve and pin may be too loose due to a dimensional discrepancy. This can cause the pin to partially or fully displace, making the strut unstable and potentially compromising the treatment's effectiveness.
Patients using the Hoffman LRF Hexapod Strut for fracture treatment or limb lengthening are most at risk. The recall affects specific model numbers sold in certain lots.
Check for model number 4935-0-040 on the Hoffman LRF Hexapod Strut. The product was sold in specific lots listed in the recall notice, including L18239 through Y16719.
Identify the lot number on the product, which is listed in the recall notice (e.g., L18239, L13690, etc.).
Reach out to Stryker for instructions on how to return or repair the device if it is affected.
The press fit connection between the Angular Sleeve and pin may be too loose due to a dimensional discrepancy, which can cause the pin to displace and lead to instability in the strut.
Model number 4935-0-040, sold in specific lots including L18239, L13690, L22250, and others listed in the recall notice.
The recall states that the strut may become unstable, but it does not specify a risk of serious injury in normal use. The hazard could compromise treatment effectiveness.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0291-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0291-2019 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.
