Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 54 Right. The device may fall off its post in 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 Stry: 54 Right Stryker Restoration Anatomic Hemispherical Shells due to a risk of the device falling off its post in packaging, which could lead to loose coating debris. This issue affects sterile surgical implants sold with specific catalog numbers and lot numbers.
The Stryker Restoration Anatomic Shell may detach from its post inside the packaging. This can cause the device to become loose with coating debris, potentially leading to contamination or injury during surgical procedures.
Surgical implants used by orthopedic surgeons for procedures involving the knee. Patients who have received this specific implant during surgery are most at risk.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 54 Right, sterile, catalog number 504-02-54C-R, and specific lot numbers listed in the recall notice.
Identify the product by checking the catalog number (504-02-54C-R) and lot numbers listed in the recall notice.
The recall indicates a potential risk of the device falling off in packaging, but the product is safe for use once properly installed in the surgical procedure.
Check the catalog number (504-02-54C-R) and lot numbers listed in the recall notice for the specific product.
Contact Howmedica directly for guidance on next steps as the recall remedy is not specified in the record.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2085-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2085-2020 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.
