Z-0103-2024 Class II Ongoing
FDA device recall Z-0103-2024 was initiated by Encore Medical, LP on Aug 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
- Oct 18, 2023
- Initiation Date
- Aug 22, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0103-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026