Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect
Orthofix is recalling Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves reduced performance of a medical device component without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Orthofix Srl is recalling specific lots of the Pelvis Sterile Kit (Sterile Gamma) due to a manufacturing defect. Complaint investigations determined that batches of drill bits included in the kits have a geometrical detail that does not correspond to the intended design.
The defect could result in lower cutting performance of the drill bits. The recall affects specific lot numbers distributed in the United States and several international countries. The product is prescription-only.
Healthcare providers and patients should stop using the affected kits and contact Orthofix Srl for further instructions or a replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
- Manufacturer
- Orthofix Srl
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 (9)
- Lot # B1202055
- B1225324
- B1225854
- B1226694
- B1228037
- B1228211
- B1228361
- B1228547
- B1231459
Distribution
Part of a larger recall action
This product is one of 31 recalled by Orthofix Srl 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.
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