Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues
Stryker is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (screw pulling out of bone) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Corporation is recalling 73 units of the Omega 4.75 mm PEEK Knotless Anchor System, Double-Double (REF 3910-500-472). The recall is due to complaints regarding difficulty in removing the driver from the screw.
High driver removal forces can lead to the screw pulling out of the bone while still attached to the driver. This issue could result in an additional anchor insertion site being used in the bone. The affected devices were distributed in 19 US states, including Georgia, New Jersey, New York, Kentucky, Maryland, Texas, Utah, Arizona, Illinois, Idaho, Colorado, Ohio, Florida, Alaska, California, Nevada, Arkansas, Maine, and Wisconsin.
Healthcare providers should stop using the affected devices and contact Stryker Corporation for further instructions. Patients who have had these devices implanted should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
- Manufacturer
- Stryker Corporation
- Affected units
- 73
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 19113AG2
- 19130AG2
- 19134AG2
- 19115AG2
- 19131AG2
- 19133AG2
- 19154AG2
- 19155AG2
- 19156AG2
- 19157AG2
- 19149AG2.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Stryker Corporation
See all →- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12