Stryker recalls Omega 4.75mm PEEK Knotless Anchor Systems due to difficulty removing the driver, which may cause screws to pull out and create additional bone 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. This recall affects medical devices used in orthopedic surgeries.
The anchors can be difficult to remove, leading to high forces that pull the screw out of the bone while still attached to the driver. This creates an additional site in the bone that may require further surgery to fix.
Orthopedic surgeons and medical professionals who use these specific Stryker Omega anchors during surgery are most at risk. Patients receiving these implants may also be affected if the anchors cause complications.
Check for the model number REF 3910-500-471 on the device, or the unique device identifier UDI 07613327464818. These anchors were sold with specific CE marking codes including 19113AG2 through 19157AG2.
Look for the model number REF 3910-500-471 or unique device identifier UDI 07613327464818 on the anchor system.
Complaints have been received about difficulty removing the driver from the screw, which can cause the screw to pull out of bone and create additional injury sites.
The recall does not specify a remedy, so check with Stryker directly for guidance on next steps.
The product may be unsafe during removal, potentially causing bone injury sites, so caution is advised.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1148-2020 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.
