Z-0706-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- January 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 686 Total Devices
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN