Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only C
FDA device recall Z-1148-2020 · posted 2020-03-02 · Terminated
Recall details
- Recalling firm
- Stryker Corporation
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 87 devices
- Distribution
- US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
- Date initiated
- 2019-07-19
- Date posted
- 2020-03-02
- Date terminated
- 2024-02-02
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Stryker All-PEEK Knotless Anchor System (K181083) | Stryker | 2018-07-23 |