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Use caution Medical device recall · FDA · Published July 19, 2019

Stryker Omega 4.75mm PEEK Knotless Anchor System Recall: Risk of Bone Injury During

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1148-2020Medical deviceStryker ›
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Contact the company

Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67378-stryker-omega-4-75mm-peek-knotless-anchor-system-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67378-stryker-omega-4-75mm-peek-knotless-anchor-system-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1148-2020

Cite this page

“Stryker Omega 4.75mm PEEK Knotless Anchor System Recall: Risk of Bone Injury During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67378-stryker-omega-4-75mm-peek-knotless-anchor-system-recall-risk. Based on FDA recall #Z-1148-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2020%22&limit=1).

The FDA announced on 2019-07-19 that Stryker Corporation voluntarily recalled the Stryker, Omega 4.75 mm PEEK Knotless Anchor System due to difficulty removing the driver from the screw. This defect could cause the screw to pull out attached to the driver, potentially requiring an additional anchor insertion site in the bone.

How to tell if you have it

  • Brand: Stryker
  • Product: Stryker, Omega 4.75 mm PEEK Knotless Anchor System, Single
  • REF: 3910-500-471
  • UDI: 07613327464818
  • Lot codes: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2, 19155AG2, 19156AG2, 19157AG2, 19149AG2
  • Quantity: 87 devices
  • Distribution: US states including GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

The hazard

According to the FDA, 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, which could result in an additional anchor insertion site in the bone being used.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since 2017-11-17. Recent Stryker recalls include a 2026-06-08 recall for the Ahto Dual Spike Tube Set due to leaking and a 2026-05-06 recall for the Neptune Smart Docking Station over electrical shock risk. Other recent recalls of similar products include the Olympus HX-400U-30 Ligating Device (2025-10-30) and the Aju Pharm Genesis Dual Thread Screw-In Anchor (2025-12-17).

How to tell if you have this one

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.

  • Brand
    Stryker
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Recall numberProduct, codes & lotsQuantity
Z-1147-2020Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197; 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.73 devices
Z-1148-2020Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197; 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.87 devices
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for the model number REF 3910-500-471 or unique device identifier UDI 07613327464818 on the anchor system.

Where it went and when

Where it was distributed

Distributed in 19 states.

Alaska: yesAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Maryland, Nevada, New Jersey, New York, Ohio, Texas, Utah, Wisconsin.

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

1. Firm started the recall: Jul 19, 201912. FDA classified it Class II: Feb 11, 202023. Published in FDA’s Enforcement Report: Feb 19, 202034. FDA terminated the recall: Feb 2, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1148-2020 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1148-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA