Howmedica recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 60 right. The device may fall from its inner packaging, causing debris to loosen. Consumers should check product details and contact Howmedica for guidance.
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 60 right) because it may fall from its inner packaging, potentially causing debris to loosen. This could lead to the device becoming loose in the package during shipping or handling.
The device may fall off its post within the inner packaging, which can cause debris to become loose. This poses a risk during shipping or handling, potentially leading to the device not being securely contained in the package.
Owners of the Stryker Orthopaedics Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, with the specific catalog number 504-02-60D-R and listed lot numbers are affected. Patients using this implant during surgery are most at risk.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 60 right, sterile, catalog number 504-02-60D-R, and the listed lot numbers. The recall applies to specific units sold with these identifiers.
Identify if your device matches the catalog number 504-02-60D-R and the listed lot numbers.
The recall is due to the device potentially falling from its inner packaging, which could cause debris to loosen. However, the hazard is not described as causing injury during normal use.
Check for the catalog number 504-02-60D-R and the specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Howmedica directly for guidance on next steps.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2091-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2091-2020 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.