Howmedica recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 58 Right due to risk of falling off packaging, potentially causing debris in the package.
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Howmedica is recalling Stryker Orthopaedics' Restoration Anatomic Hemispherical Shell (Size 58 Right) because it may fall off its post in the inner packaging. This could lead to the device becoming loose with coating debris inside the package.
The device may fall off its post within the inner packaging, causing it to become loose. This could result in coating debris being present in the package, though the hazard is limited to the packaging environment.
Patients or healthcare providers who purchased the specific Stryker Orthopaedics shell model from the listed catalog numbers and lot numbers. Those handling the packaging during use are at slightly higher risk.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right', sterile packaging, and catalog number 504-02-58D-R. The lot numbers listed in the recall include 5L0YLY, DN3EJH, and other specific codes.
Inspect the packaging for the catalog number 504-02-58D-R and lot numbers listed in the recall.
The recall states the device may fall off its post in the inner packaging, potentially causing debris. However, this hazard is limited to the packaging environment and does not indicate a risk during normal use.
Look for the catalog number 504-02-58D-R and lot numbers such as 5L0YLY, DN3EJH, or others listed in the recall.
The recall does not specify a remedy to stop use, so there is no immediate action required beyond checking the packaging details.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2089-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2089-2020 from Howmedica. 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.
