K2M Everest MI XT Outer Dilators recalled for manufacturing defect
K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing nonconformance affecting device assembly during surgical procedures. No hospitalizations or injuries are reported in the source, but the potential for surgical complications from device failure warrants high severity.
Plain-English summary
K2M, Inc. is recalling 686 Everest MI XT Outer Dilator units (Catalog Number 5101-90168) worldwide due to a manufacturing nonconformance.
Stryker reported receiving two complaints that the affected dilators do not fit together properly with inner dilators during surgical procedures. Investigation determined that units from multiple lots are affected by this manufacturing defect.
Healthcare facilities, physicians, and patients should stop using units from the affected lots immediately. Contact K2M for replacement guidance. Affected lot numbers are HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, and PCCN.
The recalled product
- Product
- Everest MI XT Outer Dilator, Catalog Number 5101-90168
- Manufacturer
- K2M, Inc
- Hazard
- Affected units
- 686
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 10888857261211
- Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · K2M, Inc
See all →- HighYukon Straight Rod spinal implants recalled for discoloration and contamination
FDA (Devices) · 2022-07-06
- HighK2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect
FDA (Devices) · 2022-03-09
- HighK2M Surgical Removal Tool Recalled for Missing Pins
FDA (Devices) · 2021-10-20
- ModerateK2M Cascadia AN Interbody Implants Recalled for Mislabeled Dimensions
FDA (Devices) · 2021-06-09
- HighK2M Cascadia lumbar implants recalled for mislabeled dimensions
FDA (Devices) · 2021-06-09
Same hazard · assembly defect
See all →- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
Similar recalls
- HighK2M Everest MI XT Tab Removal Tool Recalled for Cracking and Leakage
FDA (Devices) · 2020-12-16
- HighAgilis NxT Steerable Introducer Recalled for Dilators Too Short
FDA (Devices) · 2024-07-24
- ModerateZimmer Biomet Recalls M/L Taper Hip Prosthesis Due to Etching Error
FDA (Devices) · 2016-03-16
- HighMerit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
FDA (Devices) · 2021-08-18
- SevereZimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips
FDA (Devices) · 2017-10-04
- HighCook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error
FDA (Devices) · 2020-02-12