Howmedica recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 68 left, sterile, catalog #504-02-68F-L. 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 68 left) because it may fall off its post in the inner packaging. This could lead to loose debris inside the package. The recall affects medical devices used in orthopedic procedures.
The device may fall off its post within the inner packaging, causing loose debris to remain in the package. This could potentially lead to contamination or injury if the device is handled improperly during surgery.
Medical professionals using the Stryker Orthopaedics Restoration Anatomic Hemispherical Shell (Size 68 left) for orthopedic procedures. Patients receiving this device during surgery are most at risk.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 68 left, sterile, catalog number 504-02-68F-L, and the UDI (01)07613327012521(17). The device was sold with specific lot numbers listed in the recall notice.
Reach out to Howmedica Osteonics Corp. for specific instructions on handling the recalled device.
The recall states the device may fall off its post in packaging, causing loose debris. However, the hazard is described as low risk and does not indicate immediate danger during normal use.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 68 left, sterile, catalog number 504-02-68F-L, and the UDI (01)07613327012521(17).
Contact Howmedica Osteonics Corp. for specific instructions on handling the recalled device.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2098-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2098-2020 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.
