Z-1617-2024Class II

Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established...

Name: Z-1617-2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established...
Creator: Ebi, Llc
Published: 2024-03-22
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2024-03-22 / Open, Classified / root cause: design

FDA source

EBI, LLC began a recall of Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding... on 2024-03-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1617-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-22
Posted: 2024-04-23
Recalling firm: Ebi, LLC
Product: 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
Product code: LOF Stimulator, Bone Growth, Non-Invasive
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: 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].
Quantity in commerce: 1412 units ( 2 leads per assembly)
Distribution: US Nationwide distribution.
Product codes and lots: UD-DI: 00812301020232 All devices distributed since May 1, 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-23
Z-1617-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-23
Z-1618-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-23
Z-1619-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-23

Product code LOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)