Recalls / —

—#199600

Product

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

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K120359

Affected lot / code info

UDI/DI 00889797101011, Lot Number 1736809

Why it was recalled

Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology, Inc.

Address

1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2023-04-10

Posted by FDA

2023-04-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199600. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.