Recall Z-1148-2020— Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Corporation, initiated 2019-07-19, terminated 2024-02-02. It names one FDA 510(k) clearance: K181083. Product: Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197. Reason: 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..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-19
- Terminated
- 2024-02-02
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.