CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

Omega,. PEEK Knotless Anchor System, Single recalled by Stryker

Stryker is recalling Omega,. PEEK Knotless Anchor System, Single, distributed in 19 states. The recall was initiated on 19 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Quantity recalled87 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1148-2020
FDA event ID: 84664
Recalling firm: Stryker, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jul 2019
FDA classified: 11 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Jul 2019	Recall initiated by company
11 Feb 2020	Classified by FDA	+207 days
19 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

Where it was distributed

US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

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

Questions about this recall

Why was it recalled?

Which lots are affected?

19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Where was it sold?

US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84664

Reported	Class	Recall	Company	Reason	Where
19 Feb 2020	CLASS II	Omega,. PEEK Knotless Anchor System, Double-Double recalled by Stryker	Stryker	Other	19 states

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