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U.S. Department of Health and Human Services

Class 2 Device Recall Drop Arm Versamode"

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 Class 2 Device Recall Drop Arm Versamode"see related information
Date Initiated by FirmMarch 24, 2021
Create DateApril 05, 2021
Recall Status1 Terminated 3 on May 01, 2023
Recall NumberZ-1353-2021
Recall Event ID 87606
Product Classification Adaptor, hygiene - Product Code ILS
ProductDrop Arm Versamode"
Code Information Model: 6810A; Device Identifier: M36868101; and Lot number: BMW316BS
FEI Number 2427360
Recalling Firm/
Manufacturer		 Gf Health Products
1 Graham Field Way
Atlanta GA 30360-2808
For Additional Information Contact
516-742-3306
Manufacturer Reason
for Recall		The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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 in Commerce66 units
DistributionDistributed nationwide to CA, WI, PA, IL, and TX. Distributed internationally to Mexico and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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