Summary
The FDA issued a Class II for REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile by Orthofix Srl. Reason: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in hav.
Details
Source
Device Recall
External ID
Z-1977-2025
Action Date
2025-06-25
Status
Ongoing
Category
device
Product Description
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Lot/Code Info: Lot # B4771336 and B4771337, UDI: 18059015373653
Quantity Affected: 2 units
Reason for Recall
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Distribution
US: Unknown, OUS: Unknown
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-24
Company
Bussolengo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthofix Srl has 11 FDA actions in our database, including 1 recall and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthofix Srl) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthofix Srl have FDA actions?
Orthofix Srl has 11 FDA actions in our database, including 1 recall and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1977-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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