The Recall Desk
HighFDA (Devices)·Z-1325-2021·Announced 2021-04-07

Nuvasive Recalls PRECICE Plates Due to Biological Safety Concerns

Nuvasive Specialized Orthopedics Inc is recalling 40 PRECICE Plate units worldwide due to complaints of adverse events potentially related to biological safety.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (implantable medical device) where injury has not yet been confirmed as a direct result of the defect, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling 40 units of PRECICE Plates. These medical devices are intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The recall covers all lots of the affected product codes.

The recall was initiated due to complaints of adverse events potentially related to biological safety. The specific complaints included reports of pain and bony abnormalities at the interface between the telescoping nail segments.

The affected products were distributed worldwide, including in the United States and numerous international countries such as Argentina, Austria, Belgium, Canada, and others. The source text does not specify the number of patients affected or provide specific instructions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Manufacturer
Nuvasive Specialized Orthopedics Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
40

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 (20)

  • Left
  • 35mm
  • 0-Hole
  • 00887517021908 LP4.5-DLF31 PRECICE Plate 4.5mm Distal Femur Plate
  • 1-Hole
  • 00887517021892 LP4.5-DLF32 PRECICE Plate 4.5mm Distal Femur Plate
  • 2-Hole
  • 00887517021885 LP4.5-DLF3B PRECICE Plate 4.5mm Distal Femur Plate
  • Bump
  • 00887517021878 LP4.5-DLF40 PRECICE Plate 4.5mm Distal Femur Plate
  • 45mm
  • 00887517021861 LP4.5-DLF41 PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021854 LP4.5-DLF42 PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021847 LP4.5-DLF4B PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021830 LP4.5-DRF30 PRECICE Plate 4.5mm Distal Femur Plate
  • Right
  • 00887517021823 LP4.5-DRF31 PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021816 LP4.5-DRF32 PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021809 LP4.5-DRF3B PRECICE Plate 4.5mm Distal Femur Plate
  • 00887517021793 LP4.5-DRF40 PRECICE Plate 4.5mm Distal Femur Plate

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Nuvasive Specialized Orthopedics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Nuvasive Specialized Orthopedics Inc

See all →

Same hazard · biological safety

See all →