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Davinci Trucustom Bundle recallZ-0092-2027 · AVID Medical, Inc. · initiated Aug 10, 2026

Open, Classified

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 AVID 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

Product may be potentially contaminated with a lubricant used during the manufacturing process.

FDA root cause category: Process change control

What the company is doing

On August 10, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, segregate, and quarantine all Avid kits identified in Attachment 1. 2. Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. - Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. -Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.

Recall details

Recall number
Z-0092-2027
Status
Open, Classified
Initiated by the company
Aug 10, 2026
Posted by the FDA
Oct 7, 2026
Recalling firm
AVID Medical, Inc.
Quantity
144
Product code
LRO
Distribution
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Product description

DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;

Code information (models, lots, serial numbers)

1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 99808).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page