Fitbone Trochanteric Nail may bend during insertion and require replacement
Orthofix Srl is recalling Fitbone Trochanteric Nails (Lot B4771336 and B4771337) because the implant may bend at the distal tail during insertion, potentially requiring replacement.
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: This is an FDA Class II recall of an implantable orthopedic device where a structural defect (bending) during insertion requires device replacement. Although no injuries or hospitalizations are explicitly reported in the source, the risk involves an implantable device malfunction that could necessitate surgical revision, meeting the criteria for High severity.
Plain-English summary
Orthofix Srl is recalling the Fitbone Trochanteric Nail (REF: 99-709245, L245mm, D9mm, Sterile) in Lots B4771336 and B4771337. The device is an implantable intramedullary lengthening nail used in orthopedic surgery.
The recall is being issued because the nail may bend at the distal tail during insertion. If this occurs, the device would need to be removed and replaced during the surgical procedure.
Healthcare providers and patients who have received this implant should contact Orthofix Srl for further guidance. The FDA classification for this recall is Class II.
The recalled product
- Product
- REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
- Manufacturer
- Orthofix Srl
- Affected units
- 2
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 (2)
- Lot # B4771336 and B4771337
- UDI: 18059015373653
Distribution
Distribution scope not specified by the agency.
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