Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 68 right, sterile. Packaging may cause device to become loose in shipment, risking injury during handling.
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.
Howmed: Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 68 right, sterile implants due to a risk of the device becoming loose in its packaging. This could lead to injury if the device is mishandled during shipping or installation.
The device may fall off its post within the inner packaging. This can cause the device to become loose with coating debris, potentially leading to injury if mishandled during shipping or installation.
Surgical implants used in orthopedic procedures. Patients receiving this specific implant size and model are most at risk during handling or installation.
Check for the product name 'Stryker Restoration Anatomic Hemispherical Shell', size 68 right, sterile, catalog number 504-02-68F-R, and lot numbers listed in the recall notice.
Inspect the packaging for loose device with coating debris before use.
The recall is for packaging issues, not the product itself. It is safe when used correctly after proper installation.
Look for the product name 'Stryker Restoration Anatomic Hemispherical Shell', size 68 right, sterile, catalog number 504-02-68F-R, and the listed lot numbers.
No, the recall addresses packaging risks during shipping, not use after installation. Proper installation by a qualified professional is safe.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2099-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2099-2020 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.
