The Recall Desk
HighFDA (Devices)·Z-1467-2023·Announced 2023-05-03

Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions

Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 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: This is a Class II medical device recall involving incorrect surgical guidance information marked on bone fixation implants used in foot and ankle procedures. The labeling error constitutes a risk-of-harm for a surgical device where no injuries have yet been reported.

Plain-English summary

Wright Medical Technology, Inc. is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants, which are devices used for bone stabilization and fixation. The affected devices contain incorrect dorsiflexion descriptions that are laser marked on the parts.

Two lots are involved in this recall, affecting 50 units total. The recalled devices carry Lot Number 1737413 and UDI/DI 00889797101035. These units were distributed nationwide throughout the United States.

The FDA has classified this as a Class II medical device recall based on the marking discrepancy identified on these surgical implants.

The recalled product

Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • mis-labeling

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 00889797101035
  • Lot Number 1737413

Distribution

Distributed nationwide across the United States.

Related recalls

Same category