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Biomet OrthoPak Non-invasive Bone Growth Stimulator System recallZ-1617-2024 · Ebi, LLC · initiated Mar 22, 2024

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 Ebi, LLC 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

Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

FDA root cause category: Device Design

What the company is doing

ZimVie issued Urgent Medical Device Correction letter to Patients, Physicians, Sales Representatives on 3/22/24 . Letter states reason for recall, health risk and action to take: 1. Review this notification for awareness of the contents. 2. Before each use, inspect your device s lead wires (black cable) for damage. If found to be damaged, contact Customer Service at 1-800-526-2579 x 6000 for a complimentary replacement. 3. Complete the Acknowledgement and Receipt Form either by scanning the QR code on the postcard included with this letter and completing the online form or mailing back the completed postcard. To complete your Acknowledgement, you will need to include your Unique Patient Reference Number included on the top of the first page of this letter. This acknowledgement should be completed even if you do not have affected product. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-526-2579 x 6000. Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day. Alternatively, your questions may be emailed to [email protected].

Recall details

Recall number
Z-1617-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Apr 23, 2024
Recalling firm
Ebi, LLC
Quantity
1412 units ( 2 leads per assembly)
Product code
LOF
FDA submissions
P850022
Distribution
US Nationwide distribution.

Product description

Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

Code information (models, lots, serial numbers)

UD-DI: 00812301020232 All devices distributed since May 1, 2023

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

11 devices cleared under P850022 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94291).

Sources and updates

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