Date Initiated by Firm | June 19, 2023 |
Date Posted | August 03, 2023 |
Recall Status1 |
Completed |
Recall Number | Z-2287-2023 |
Recall Event ID |
92732 |
510(K)Number | K103136 |
Product Classification |
Plate, bone - Product Code JEY
|
Product | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
Identification number: SD900.101 |
Code Information |
UDI: 05420060351013
Lot Case Number: MU23-JOQ-LID
|
Recalling Firm/ Manufacturer |
Materialise N.V. Technologielaan 15 Heverlee Belgium
|
For Additional Information Contact | SAME 3216396611 |
Manufacturer Reason for Recall | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
FDA Determined Cause 2 | Process change control |
Action | Synthes sales representative was made aware of the issue on 19 June 2023, by phone and email. Materialise requested the product to be returned on 19 June 2023,
Synthes sales representative confirmed that surgery will be performed
without guides and will return the case. The guides were returned/received at Materialise on 23 June 2023. |
Quantity in Commerce | 1 unit |
Distribution | US Nationwide distribution in the state of KY. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JEY
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