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BEAR Implant (Bridge-Enhanced ACL Restoration) recallZ-0479-2026 · Miach Orthopaedics · initiated Feb 2, 2023

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 Miach Orthopaedics 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

The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

FDA root cause category: Under Investigation by firm

What the company is doing

On January 30, 2023 RE: BEAR Implant Hydration memo emails were sent to sales staff. If you observe an implant that hydrates too quickly (e.g., less than 30 seconds) and appears that it may not remain intact upon insertion into the knee, do not attempt to implant the device. We would recommend you always have a backup device available to address such circumstances. We plan to revise the Tips and Pearls document, ML-1027, to provide further instructions/details on how to properly hydrate the BEAR device. In the meantime, one way to avoid shortened hydration time is to consider hydrating the dense side of the implant first and continue toward the porous side . To date, all reports of this observation have involved Lot # 7008409. As a precaution and to ensure customer satisfaction, we are asking that you return all devices from this lot that are currently in your trunk stock (in your possession). Chris Brown will work with you to coordinate returns as well as replacing these trunk stock devices. Please contact me ([email protected]) or Arjun ([email protected]) if you have questions.

Recall details

Recall number
Z-0479-2026
Status
Open, Classified
Initiated by the company
Feb 2, 2023
Posted by the FDA
Nov 7, 2025
Recalling firm
Miach Orthopaedics
Quantity
167 units
Product code
QNI
FDA submissions
K243578
Distribution
US Nationwide distribution.

Product description

BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

Code information (models, lots, serial numbers)

Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;

Devices named in this recall

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

Sources and updates

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