FDA Medical Device Recalls (openFDA)
Gf Health Products: Drop Arm Versamode"
- Recall number
- Z-1353-2021
- Recalling firm
- Gf Health Products
- Product
- Drop Arm Versamode"
- Status
- Terminated
- Initiated
- 2021-03-24
- Posted
- not on file
- Terminated
- 2023-05-01
- Reason
- The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
- Root cause
- Nonconforming Material/Component
- Action
- A Recall notification letter titled, "URGENT CORRECTION AND REMOVAL" was sent to consignees on 03/24/2021 via FedEx priority. The consignees were instructed to: "The replacement of the front casters is required to ensure proper operation of the Versamode, and to eliminate any potential safety concern. 1. Contact GF Health Products at 1-888-974-4347 or fieldcorrection@grahamfield.com within ten (10) business days from receipt of this notification to schedule your front caster replacement order. Replacement front casters will be provided at NO CHARGE for Versamodes with lot number BMW316BS. 2. Upon receipt of the replacement casters, follow the enclosed instructions Replacing Your Lumex Drop Arm Versamode Front Casters. (Attachment 1) 3. Dispose of the incorrect, replaced casters in accordance with Federal, State, or Local regulations. 4. Fill out and sign the Certification of Replacement Agreement. (Attachment 2) 5. Return the completed Certification of Replacement Agreement to: fieldcorrection@grahamfield.com or Fax: 770-368-3333."
- Quantity
- 66 units
- Distribution
- Distributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.
- Lot, serial or model codes
- Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILS
- Firm FEI
- 2427360
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28