Recall Z-0243-2023— Altimate Medical, Inc.

Name: FDA recall Z-0243-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-04

Class II · Terminated

Class II FDA medical device recall by Altimate Medical, Inc., initiated 2022-10-04, terminated 2023-08-31. It names one FDA 510(k) clearance: K091242. Product: EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.. Reason: Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position..

Recalling firm: Altimate Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-10-04
Terminated: 2023-08-31
Firm location: Morton, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K091242 — BANTAMAltimate Medical, Inc.·cleared 2009-07-06

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

EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

Reason for recall

Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.

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