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EasyStand Bantam, with the following sizes recallZ-0243-2023 · Altimate Medical, Inc. · initiated Oct 4, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Altimate Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Pending

What the company is doing

Altimate Medical notified consignees via email on about 10/04/2022. The email contained a letter which instructed consignees to examine unit on hand to determine if it is affected, contact Customer Service if assistance is needed determining if unit is affected, cease distribution or use of affected device, replace bracket and confirm unit is corrected and functioning properly by returning the provided verification document.

Recall details

Recall number
Z-0243-2023
Status
Terminated
Initiated by the company
Oct 4, 2022
Posted by the FDA
Nov 16, 2022
Recalling firm
Altimate Medical, Inc.
Quantity
14 devices
Product code
INO
FDA submissions
K091242
Distribution
Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.

Product description

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

Code information (models, lots, serial numbers)

a. UDI: (01)10858921006062(21)V2005693010, (01)10858921006062(21)V2005693012, (01)10858921006062(21)V2005693015, (01)10858921006062(21)V2005693017, (01)10858921006062(21)V2005694003, (01)10858921006062(21)V2005694009, (01)10858921006062(21)V2005694020, (01)10858921006062(21)V2005695010, (01)10858921006062(21)V2005695011, (01)10858921006062(21)V2005695018, (01)10858921006062(21)V2005695019, (01)10858921006062(21)V2005695020; b. UDI: (01)10858921006079(21)V1005700003, (01)10858921006079(21)V1005700009

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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