| Date Initiated by Firm | September 24, 2024 |
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| Date Posted | June 13, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1977-2025 |
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| Recall Event ID |
96905 |
| 510(K)Number | K233867 |
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| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
| Product | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile |
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| Code Information |
Lot # B4771336 and B4771337, UDI: 18059015373653 |
| FEI Number |
3002807827
|
Recalling Firm/
Manufacturer |
Orthofix Srl
Via Delle Nazioni 9
Bussolengo Italy
|
| For Additional Information Contact | Gianluca Ricadona
+39 045 671900 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Use error |
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| Action | No official notification was sent to customers. Orthofix representative was present during the first clinical case and both devices were returned as part of the complaint investigation process. |
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| Quantity in Commerce | 2 units |
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| Distribution | US: Unknown, OUS: Unknown |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HSB
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