Z-1466-2023Class II

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

Name: Z-1466-2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Creator: Wright Medical Technology, Inc.
Published: 2023-04-10
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2023-04-10 / Open, Classified / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation on 2023-04-10. FDA classified it as Class II and gives the reason as "Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1466-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-10
Posted: 2023-04-26
Recalling firm: Wright Medical Technology Inc
Product: stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Product code: HRS Plate, Fixation, Bone
Reason for recall: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 41 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00889797101011, Lot Number 1736809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1466-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1466-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-26
Z-1467-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-26

Product code HRS

K120359Class IIOrtholoc 3Di Hallux SystemWrightmedicaltechnologyinc / cleared 2012-05-03

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)