The Recall Desk
HighFDA (Devices)·Z-1466-2023·Announced 2023-05-03

Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings

Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving incorrect labeling on a surgical implant device that could potentially impact surgical accuracy. No illnesses or injuries have been reported, placing this in the risk-of-harm category.

Plain-English summary

Wright Medical Technology, Inc. is recalling the Stryker ORTHOLOC 3Di Fusion Plate MTP Right (Model REF 58A220RT), a device used for bone stabilization and fixation in orthopedic surgery.

The recalled devices contain incorrect dorsiflexion descriptions laser marked on the parts. Incorrect markings on surgical implants could potentially lead to misidentification or improper use during surgical procedures.

A total of 41 units were distributed nationwide in the affected lots. The identified lot number is 1736809 (UDI/DI 00889797101011). This recall has been classified by the FDA as a Class II recall.

The recalled product

Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic implant
Hazard
  • incorrect-labeling
  • surgical-marking-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00889797101011
  • Lot Number 1736809

Distribution

Distributed nationwide across the United States.

Related recalls

Same category