Stryker recalls specific Omega 4.75mm PEEK Knotless Anchor Systems due to difficulty removing the driver, which may cause screws to pull out of bone, creating additional injury sites.
Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
Stryker is recalling certain Omega 4.75mm PEEK Knotless Anchor Systems because they can be difficult to remove, potentially causing screws to pull out of bone and creating additional injury sites.
The anchors can be difficult to remove from screws, leading to high removal forces that may cause the screw to pull out of the bone while still attached to the driver. This creates an additional injury site in the bone.
Orthopedic surgeons and medical professionals using the recalled anchors during bone surgery are most at risk. Patients who have received the recalled anchors may also be affected.
Check for the model number 3910-500-472 or the unique device identifier (UDI) 07613327464832 on the product packaging. The product is sold under the brand Stryker and is used in orthopedic surgery.
Verify the model number 3910-500-472 or UDI 07613327464832 on the product packaging to confirm if it is recalled.
Stryker recalls these anchors because complaints indicate difficulty removing the driver, which can cause screws to pull out of bone and create additional injury sites.
The recall record does not specify a remedy, so no action is required beyond checking if the product matches the recalled model or UDI.
The recall indicates a risk of injury during removal, so caution is advised when using these anchors in orthopedic procedures.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1147-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1147-2020 from Stryker. 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.
