Recall Z-0281-2024— Encore Medical, LP

Name: FDA recall Z-0281-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-25

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-09-25. It names one FDA 510(k) clearance: K172351. Product: RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.. Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-09-25
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K172351 — AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P.·cleared 2017-10-30

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

RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.

Reason for recall

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

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