The Recall Desk
HighFDA (Devices)·Z-1323-2021·Announced 2021-04-07

Nuvasive PRECICE STRYDE Intramedullary Nail Recall for Biological Safety Concerns

Nuvasive Specialized Orthopedics is recalling PRECICE STRYDE intramedullary nails due to complaints of adverse events potentially related to biological safety, including pain and bony abnormalities.

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 a risk-of-harm product (implanted medical device) with reported adverse events (pain, bony abnormalities) but does not explicitly state that hospitalization or serious injury occurred, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been definitively reported as severe in the text.

Plain-English summary

Nuvasive Specialized Orthopedics Inc is recalling 2,360 units of PRECICE STRYDE intramedullary nails. 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 devices were distributed worldwide, including in the United States and numerous international markets such as Argentina, Austria, Belgium, Canada, and others. The source text does not specify the exact number of patients affected or the specific dates of distribution. Patients who have received these devices should contact their healthcare provider for further evaluation and guidance.

The recalled product

Product
PRECICE STRYDE - 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
2,360

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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