Recall Z-0625-2024— Encore Medical, LP

Name: FDA recall Z-0625-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-05

Class II · Completed

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-10-05. It names one FDA 510(k) clearance: K051075. Product: Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797. Reason: Mislabeling.

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Completed
Initiated: 2023-10-05
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K051075 — ENCORE REVERSE SHOULDER PROSTHESISEncore Medical L.P.·cleared 2005-05-27

K-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

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

Reason for recall

Mislabeling

Data sourced from openFDA. This site is unofficial and independent of the FDA.