Orthofix Pelvis Sterile Kit Drill Bits Recalled for Design Defect
Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering 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 leading to lower cutting performance, which is a risk-of-harm product issue where specific injuries have not yet been reported in the source text.
Plain-English summary
Orthofix Srl is recalling specific lots of the Pelvis Sterile Kit (Catalogue Number: 99-93501) due to a design defect in the drill bits. The affected lots are B1200694, B1204116, B1224715, and B1232315.
Complaint investigations determined that the drill bits in these batches have a geometrical detail that does not correspond to the intended design. This discrepancy could result in lower cutting performance. The agency has classified this as a Class II recall.
The products were distributed in the United States (including Puerto Rico) and various international locations. Healthcare providers and facilities should stop using the affected lots and contact Orthofix Srl for further instructions.
The recalled product
- Product
- ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
- 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 (4)
- Lot # B1200694
- B1204116
- B1224715
- B1232315
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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