Howmedica recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 56 Left. Packaging may fall off causing loose device with debris. Stop using if affected.
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.
Howmed: Howmedica Osteonics recalls Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 56 Left. The device may fall off its post in packaging, potentially causing loose device with debris. This could lead to injury if the device is mishandled during use.
The device may fall off its post within the inner packaging. This can cause the device to become loose with coating debris, potentially leading to injury if mishandled during surgical procedures.
Orthopedic surgeons and medical staff who use the Stryker Orthopaedics Restoration Anatomic Hemispherical Shell Size 56 Left for surgeries. Patients receiving this specific implant are at risk if the device falls during handling.
Check for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 56 left, sterile, catalog number 504-02-56D-L, and UDI (01)07613327012361(17). Lot numbers include 4J3N24 through P32YRY.
Inspect the packaging for the device falling off its post with coating debris.
The recall states the device may fall off its post in packaging, potentially causing loose device with debris. However, the hazard is described as a packaging issue, not a direct risk during normal use.
Look for the product name 'Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell', size 56 left, sterile, catalog number 504-02-56D-L, and UDI (01)07613327012361(17). Lot numbers include 4J3N24 through P32YRY.
The recall does not specify a remedy. Check the packaging for loose device with debris 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-2086-2020 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2086-2020 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.
