FDA Medical Device Recalls (openFDA)
K2M, Inc: Everest MI XT Inner Dilator, Catalog Number 5101-90167
- Recall number
- Z-0705-2022
- Recalling firm
- K2M, Inc
- Product
- Everest MI XT Inner Dilator, Catalog Number 5101-90167
- Status
- Open, Classified
- Initiated
- 2022-01-13
- Posted
- not on file
- Terminated
- not on file
- 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 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
- Quantity
- 686 Total Devices
- Distribution
- Worldwide distribution - US Nationwide.
- Lot, serial or model codes
- GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 3008599177
- Firm city
- Leesburg
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28