Recall Z-2331-2021— Encore Medical, LP

Name: FDA recall Z-2331-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-28

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2021-06-28. It names one FDA 510(k) clearance: K162024. Product: AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000. Reason: Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2021-06-28
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K162024 — AltiVate Anatomic Shoulder SystemEncore Medical L.P.·cleared 2016-11-21

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

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

Reason for recall

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

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