Recall Z-0706-2022 ยท KWP Appliance, Fixation, Spinal Interlaminal
K2M, Inc
Everest MI XT Outer Dilator, Catalog Number 5101-90168
| Date | Jan 13, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 confir |
| Quantity | 686 Total Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.