—#179066

Product

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K181083
Affected lot / code info: 19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On July 23, 2019, a "Urgent Medical Device Recall Notification" was emailed to sales representatives. In addition to informing consignees on the cause of the recall, the following action was requested: 1. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by August 15, 2019. 2.If affected product is found in your inventory, segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). Also fill out Attachment A and return to endorecall@stryker.com. 3.If affected product is found at account(s), please complete both steps below: a.Provide attached memo (Attachment B) to the account(s) to acknowledge the removal of devices and send completed memo back to endorecall@stryker.com. b.Segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). 4.If no product is found in your inventory or at your account(s), complete acknowledgement form on Attachment A and return it back to endorecall@stryker.com.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

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

Timeline

Recall initiated: 2019-07-19
Posted by FDA: 2020-03-02
Terminated: 2024-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179066. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.