Howmedica recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 66 left. The device may fall off its post in packaging, causing loose debris. Consumers should contact Howmedica for details.
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 66 left) because it may fall off its post in the inner packaging. This could lead to loose debris inside the package, though the hazard is limited to the packaging stage and not during normal use.
The device may fall off its post within the inner packaging, causing loose debris. This could potentially lead to contamination or damage during handling, but the hazard is confined to the packaging stage and does not affect the device during normal surgical use.
Patients or healthcare providers who own or use this specific surgical implant. The risk is minimal as the hazard occurs only during packaging handling, not during surgical use.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 66 left, sterile, catalog number 504-02-66F-L, and the listed lot numbers. The device was sold with a unique device identifier (UDI) starting with (01)07613327012491(17).
Identify the product by checking the catalog number 504-02-66F-L and lot numbers listed in the recall notice.
No, the hazard occurs only in the packaging stage, not during surgical use.
Check for the catalog number 504-02-66F-L and lot numbers listed in the recall notice.
Contact Howmedica directly for specific instructions as the recall remedy is not stated 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-2095-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2095-2020 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.