Z-0705-2022Class II

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Name: Z-0705-2022 Everest MI XT Inner Dilator, Catalog Number 5101-90167
Creator: K2M, Inc
Published: 2022-01-13
License: https://open.fda.gov/license/

K2M, Inc / initiated 2022-01-13 / Open, Classified / root cause: manufacturing process

FDA source

K2M, Inc began a recall of Everest MI XT Inner Dilator, Catalog Number 5101-90167 on 2022-01-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0705-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-13
Posted: 2022-03-01
Recalling firm: K2M, Inc
Product: Everest MI XT Inner Dilator, Catalog Number 5101-90167
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected], 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 in commerce: 686 Total Devices
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0705-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0706-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code KWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)