Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Recall
- Recall Number
- Z-1148-2020
- Event Number
- 84664
- Firm
- Stryker Corporation
- FEI Number
- 2936485
- Product Code
- MBI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 19, 2019
- Posted
- March 2, 2020
- Terminated
- February 2, 2024
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
Description
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
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.
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 [email protected] to arrange for product return and issuance of credit or replacement (upon availability). Also fill out Attachment A and return to [email protected]. 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 [email protected]. b.Segregate the product and call Stryker customer service at 1-866-596-2022 or email [email protected] 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 [email protected].
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87 devices