Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect
Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.
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: The recall is classified as FDA Class II. The hazard involves a design defect in a medical device that could affect performance, but the source text does not report any injuries, illnesses, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthofix Srl is recalling specific lots of the Pelvis Sterile Kit (Catalogue Number 99-93501US) due to a manufacturing defect. The recall was initiated after complaint investigations determined that batches of drill bits included in the kit 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 affected product is identified by Lot # B1225391 and UDI (01)180S4242S11281. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The product was distributed in the United States (including Puerto Rico) and in numerous countries outside the US, including Kuwait, Australia, Saudi Arabia, and others. Healthcare providers and facilities should stop using the affected lots and contact Orthofix Srl for instructions on return or replacement.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
- 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 (1)
- Lot # B1225391
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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