Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues
Stryker is recalling 87 Omega 4.75 mm PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a mechanical defect that could lead to the screw pulling out of the bone, which is a risk-of-harm product where injury has not yet been explicitly reported in the source text.
Plain-English summary
Stryker Corporation is recalling 87 units of the Omega 4.75 mm PEEK Knotless Anchor System, Single, REF 3910-500-471. The affected devices are sterile, prescription-only medical implants used for bone anchoring. The recall is limited to specific lot codes: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2, 19155AG2, 19156AG2, 19157AG2, and 19149AG2.
The recall was initiated after complaints were received regarding difficulty in removing the driver from the screw. The source text notes that high driver removal forces can lead to the screw pulling out of the bone while still attached to the driver. This mechanical failure could result in the use of an additional anchor insertion site in the bone.
The affected devices were distributed in the United States to the following states: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, and WI. Healthcare providers and patients who have received these specific devices should contact Stryker Corporation or their healthcare provider for instructions on next steps.
The recalled product
- Product
- Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
- Manufacturer
- Stryker Corporation
- Affected units
- 87
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.
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