Recall Z-0117-2021— Encore Medical, LP

Name: FDA recall Z-0117-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Terminated

Class II FDA medical device recall by Encore Medical, LP, initiated 2020-08-31, terminated 2024-04-19. It names one FDA 510(k) clearance: K172351. Product: AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.. Reason: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Terminated: 2024-04-19
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

AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.

Reason for recall

Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.

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