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Open, Classified

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

FDA Recall Z-0287-2024 · Posted 2023-11-09

Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2023-09-13
Product Quantity19 kits

Reason for Recall

Expired product distributed

Firm Action

On 09/27/2023, Stryker issued a "Urgent Medical Device Recall Notification" to affected consignees via mail. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. 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 November 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. 4. Please complete the response form on Appendix A of this notice and return devices back to Stryker Endoscopy. a. Please call Customer Service at 1-866-596-2022 or email [email protected] to arrange for product return. 5. If no product is found, complete acknowledgement form and return it back to Stryker.

Root Cause

Process control

Distribution Pattern

US: NH, TX, NY, NJ, OH, MN OUS: None

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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