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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet OrthoPak Noninvasive Bone Growth Stimulator System

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  Class 2 Device Recall Biomet OrthoPak Noninvasive Bone Growth Stimulator System see related information
Date Initiated by Firm March 22, 2024
Date Posted April 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1617-2024
Recall Event ID 94291
PMA Number P850022 
Product Classification Stimulator, bone growth, non-invasive - Product Code LOF
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
Code Information UD-DI: 00812301020232 All devices distributed since May 1, 2023
Recalling Firm/
Manufacturer		 EBI, LLC
1 Gatehall Dr Ste 303
Parsippany NJ 07054-4514
For Additional Information Contact Customer Service
800-526-2579 Ext. 60000
Manufacturer 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
FDA Determined
Cause 2		 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 ebi.csorders@zimvie.com.
Quantity in Commerce 1412 units ( 2 leads per assembly)
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LOF and Original Applicant = EBI, LLC
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