The Recall Desk
HighFDA (Devices)·Z-1324-2021·Announced 2021-04-07

Nuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns

Nuvasive Specialized Orthopedics is recalling 226 Precice Bone Transport nails due to complaints of pain and bony abnormalities 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 the source text describes adverse events (pain and bony abnormalities) without reporting hospitalizations or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as severe.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling 226 units of the Precice Bone Transport medical device. The device is intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. 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 recall covers all lots of the affected product codes, which include various sizes and configurations for the femur and tibia.

The affected devices were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, and various European and Middle Eastern countries. Patients who have had this device implanted should contact their healthcare provider for guidance on next steps.

The recalled product

Product
Precice Bone Transport - 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
226

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)

  • 10.0mm x 360mm
  • 5/10cm ST
  • 887517981554 BT10-10A360-5 Retrograde Femur 10¿ Bend
  • 887517981547 BT10-10A360-7 Retrograde Femur 10¿ Bend
  • 7/10cm ST
  • 887517981530 BT10-10A380-5 Retrograde Femur 10¿ Bend
  • 10.0mm x 380mm
  • 887517981523 BT10-10A380-7 Retrograde Femur 10¿ Bend
  • 887517981516 BT10-10A400-5 Retrograde Femur 10¿ Bend
  • 10.0mm x 400mm
  • 887517981509 BT10-10A400-7 Retrograde Femur 10¿ Bend
  • 887517981493 BT10-10B360-5 Antegrade Femur Piriformis Straight
  • 887517981486 BT10-10B360-7 Antegrade Femur Piriformis Straight
  • 887517981479 BT10-10B380-5 Antegrade Femur Piriformis Straight
  • 887517981462 BT10-10B380-7 Antegrade Femur Piriformis Straight
  • 887517981455 BT10-10B400-5 Antegrade Femur Piriformis Straight
  • 887517981448 BT10-10B400-7 Antegrade Femur Piriformis Straight
  • 887517981431 BT10-10BT360-5 Antegrade Femur Piriformis Straight
  • 887517981424 BT10-10BT360-7 Antegrade Femur Piriformis Straight
  • 887517981417 BT10-10BT380-5 Antegrade Femur Piriformis Straight

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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