Agency classClass IIOur severity:High FDA (Devices)·Z-0069-2021·Announced 2020-10-14

Nuvasive Precice Bone Transport System Recall for Distal Plug Disassociation Risk

Nuvasive is recalling 41 Precice Bone Transport System units because standard removal tools can cause the distal plug to disassociate during explantation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 the hazard involves a risk of harm (device disassociation) during a medical procedure, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling 41 units of the Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend component. This component is part of the orthopedic Precice Bone Transport System, which includes an intramedullary nail, locking screws, reusable instruments, and a hand-held External Remote Controller (ERC).

The recall was initiated because standard removal tools used during explantation can generate sufficient forces to cause the distal plug to disassociate from the bone transport system. The affected units were distributed worldwide, including in the United States, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, the United Kingdom, Germany, the UAE, Luxembourg, Israel, and the Netherlands.

Healthcare providers and patients should contact Nuvasive Specialized Orthopedics Inc for further instructions regarding the recall and potential replacement or repair of the affected devices.

The recalled product

Product: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
Manufacturer: Nuvasive Specialized Orthopedics Inc
Category: Medical Device — Orthopedic Implant
Hazard: device-disassociation
Affected units: 41

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 (11)

3-HOLE10MM X 360MM
3-HOLE11.5MM X 340MM
3-HOLE11.5MM X 320MM
3-HOLE10MM X 320MM
3-HOLE11.5MM X 300MM
3-HOLE10MM X 340MM
3-HOLE10MM X 400MM
3-HOLE10MM X 380MM
3-HOLE11.5MM X 280MM
3-HOLE10MM X 300MM
7/10CM STK Lot/Serial Number: 9072221AAA

Distribution

Distributed nationwide across the United States.

Same manufacturer · Nuvasive Specialized Orthopedics Inc

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Same hazard · device disassociation