Recall Z-0706-2022

Reason for recall

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

FDA-determined cause: Process control

Action taken

URGENT: MEDICAL DEVICE RECALL notification letters dated 1/13/22 were sent to customers. Hospital Quality or Materials Managers/Inventory Contacts instructions: Actions needed 1. Immediately check your internal inventory to locate the product listed on the attached Business Reply Form and remove them from their point of use. 2. Use the Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 3. Return the enclosed Business Reply Form by email to Spine-RegulatoryActions@Stryker.com or fax to 201- 575-4675 to confirm receipt of this notification/document product segregation. Your account s Stryker Spine Sales Representative will arrange for retrieval and removal of any instruments associated with this recall. 4. In the interim, until units can be removed from your facility by Stryker, there are no additional actions that users can and should take once the product has been segregated and removed from point of use. - If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at Spine-RegulatoryActions@Stryker.com, or contact your local Sales representative. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. 7. Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by using Stryker s online reporting site: https://www.stryker.com/productexperience. Additionally, adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adver