Recall Z-2148-2025— Encore Medical, LP
Class II · Ongoing
Class II FDA medical device recall by Encore Medical, LP, initiated 2025-06-12. It names one FDA 510(k) clearance: K203557. Product: Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA. Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint..
- Recalling firm
- Encore Medical, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-12
- 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
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA
Reason for recall
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Data sourced from openFDA. This site is unofficial and independent of the FDA.