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U.S. Department of Health and Human Services

Class 2 Device Recall stryker ORTHOLOC

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 Class 2 Device Recall stryker ORTHOLOCsee related information
Date Initiated by FirmApril 10, 2023
Date PostedApril 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1467-2023
Recall Event ID 92078
510(K)NumberK120359 
Product Classification Plate, fixation, bone - Product Code HRS
Productstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Code Information UDI/DI 00889797101035, Lot Number 1737413
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
Manufacturer Reason
for Recall		Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
FDA Determined
Cause 2		Employee error
ActionThe firm issued an URGENT: MEDICAL DEVICE RECALL notice to its sales representatives and distributors on 04/10/2023 by email and followed with letters disseminated to the remaining consignees via tracked FedEx mailing on Wednesday, April 12. The notice explained the issue and the risk and requested the following actions be taken: Identify all affected products and isolate/quarantine to prevent accidental use. All parties that further distributed the product were directed to notify anyone to the recipients of the affected products. The firm is seeking return of the products.
Quantity in Commerce50 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = HRS
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