Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 66 right, sterile, catalog #504-02-66F-R. Packaging may fall off, causing loose device with debris. Stop using immediately.
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 Restoration Anatomic Hemispherical Shell Size 66 right implants due to a risk that the device may fall off its post in the packaging. This could lead to loose device with coating debris, potentially causing injury during handling or use.
The device may fall off its post within the inner packaging, which can cause the device to become loose with coating debris. This poses a risk during handling or use, but the hazard is not described as causing serious injury in normal use.
Patients who received the specific Stryker Restoration Anatomic Hemispherical Shell Size 66 right implant with catalog number 504-02-66F-R are affected. Surgeons and medical staff handling these implants during surgery are most at risk.
Check for the Stryker Restoration Anatomic Hemispherical Shell, Size 66 right, sterile, catalog number 504-02-66F-R. The device has a unique identifier (UDI) and specific lot numbers listed in the recall notice.
Immediately stop using the recalled implant if you have it.
The recall states the device may fall off its post in packaging, causing loose device with coating debris. However, the hazard is described as low risk and not causing serious injury in normal use.
Check for the Stryker Restoration Anatomic Hemispherical Shell, Size 66 right, sterile, catalog number 504-02-66F-R with the listed lot numbers or unique identifiers.
Stop using it immediately and contact Howmedica for further instructions.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2097-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2097-2020 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.
