Everest MI XT Outer Dilator recall
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Why was Everest MI XT Outer Dilator 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
- Product
- Everest MI XT Outer Dilator, Catalog Number 5101-90168
- Recalling firm
- K2M, Inc
- Quantity
- 686 Total Devices
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)