Recall Z-0103-2024— Encore Medical, LP
Class II · Ongoing
Class II FDA medical device recall by Encore Medical, LP, initiated 2023-08-22. It names one FDA 510(k) clearance: K190057. Product: EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H. Reason: 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)..
- Recalling firm
- Encore Medical, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-22
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.