ORTHOLOC 3Di recallZ-1467-2023 · Wright Medical Technology, Inc. · initiated Apr 10, 2023
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Wright Medical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
FDA root cause category: Employee error
What the company is doing
The 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.
Recall details
- Recall number
- Z-1467-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 10, 2023
- Posted by the FDA
- Apr 26, 2023
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 50 units
- Product code
- HRS
- FDA submissions
- K120359
- Distribution
- US Nationwide distribution.
Product description
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Code information (models, lots, serial numbers)
UDI/DI 00889797101035, Lot Number 1737413
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ORTHOLOC 3DI 58A221RTWright Medical Technology, Inc. · Plate, fixation, bone1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92078).
- Z-1466-2023 · Open, Classifiedstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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