Z-0103-2024 Class II Ongoing
FDA device recall Z-0103-2024 was initiated by Encore Medical, LP on August 22, 2023 and is designated Class II. Reason for recall: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery … The recall status is ongoing. Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
Reason for Recall
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Distribution Pattern
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Code Information
UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028