Everest MI XT Inner Dilator, Catalog Number 5101-90167
Reported: March 9, 2022 Initiated: January 13, 2022 #Z-0705-2022
Product Description
Everest MI XT Inner Dilator, Catalog Number 5101-90167
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.
Details
- Recalling Firm
- K2M, Inc
- Units Affected
- 686 Total Devices
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Leesburg, VA
Frequently Asked Questions
What product was recalled? ▼
Everest MI XT Inner Dilator, Catalog Number 5101-90167. Recalled by K2M, Inc. Units affected: 686 Total Devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0705-2022.
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