The Recall Desk
ModerateFDA (Devices)·Z-1349-2021·Announced 2021-04-14

Nuvasive PRECICE Limb Lengthening System Recalled for Missing Biological Assessments

Nuvasive Specialized Orthopedics is recalling PRECICE limb lengthening devices because they lack full biological assessments and are not indicated for patients under 18.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of biological assessments and a specific age restriction (under 18), which constitutes a moderate risk of harm without reported fatalities or serious injuries in the source text.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling the PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System, including end caps, locking screws, and intramedullary rods. The recall involves 10,657 units that were distributed worldwide, including nationwide in the United States.

The recall is being conducted because the devices do not have the full complement of biological assessments for all potential patients. As a result, the devices are not indicated for use in individuals under the age of 18 years old.

Patients who have received these implants should contact their healthcare provider for guidance. The recall covers all lots manufactured between April 2015 and February 2021.

The recalled product

Product
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/
Manufacturer
Nuvasive Specialized Orthopedics Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10,657

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)

  • CPA2-000
  • CPA2-005
  • CPA2-010
  • CPA2-015
  • CPA2-020
  • CPA3-000
  • CPA3-005
  • CPA3-010
  • CPA3-015
  • CPA3-020
  • Locking screws: LSB3-020
  • LSB3-025
  • LSB3-030
  • LSB3-035
  • LSB3-040
  • LSB3-045
  • LSB3-050
  • LSB3-055
  • LSB3-060
  • LSB3-065

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 →

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