X-Change Wall Mesh (Howmedica Osteonics) – Incorrect Mesh Type (2019)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

Recommended Action

Per FDA guidance

Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Complete customer response form and return the form and any affected devices to the following address. (Please complete this form regardless of whether your organization has product to return. This will preclude the need for Stryker to send any reminder notice.) ATTN: David Nihill, Limerick Finished Goods Centre C/O Flextronics Global Services Ireland Unit 1 Raheen Business Park Raheen, Limerick.