PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Reported: April 7, 2021 Initiated: February 12, 2021 #Z-1323-2021
Product Description
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Reason for Recall
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Details
- Recalling Firm
- Nuvasive Specialized Orthopedics Inc
- Units Affected
- 2360 units
- Distribution
- Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
- Location
- Aliso Viejo, CA
Frequently Asked Questions
What product was recalled? ▼
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.. Recalled by Nuvasive Specialized Orthopedics Inc. Units affected: 2360 units.
Why was this product recalled? ▼
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Moderate. Recall number: Z-1323-2021.
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