Recall Z-0706-2022— K2M, Inc
Class II · Ongoing
Class II FDA medical device recall by K2M, Inc, initiated 2022-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Everest MI XT Outer Dilator, Catalog Number 5101-90168. 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..
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-13
- Firm location
- Leesburg, VA, United States
Product description
Everest MI XT Outer Dilator, Catalog Number 5101-90168
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.