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.
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 2/5 (Moderate).
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.
See all 31 products in this recall →Related recalls
Same manufacturer · Orthofix Srl
See all →- HighFitbone Trochanteric Nail may bend during insertion and require replacement
FDA (Devices) · 2025-06-25
- ModerateOrthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw
FDA (Devices) · 2019-11-20
- ModerateOrthofix Drill Bits Recalled for Geometrical Design Deviation
FDA (Devices) · 2019-11-20
Same hazard · design defect
See all →- HighUnited Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
FDA (Devices) · 2026-08-12
- SevereDuraMax hemodialysis catheter sheath introducer may not split as intended
FDA (Devices) · 2026-04-01
- SevereBioFlo DuraMax catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereMerit 16F splittable sheath introducer recalled as Class I bulk product
FDA (Devices) · 2026-04-01
Similar recalls
- SevereOrthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighSynthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns
FDA (Devices) · 2024-03-13
- HighOrthofix Recalls TN Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- HighOrthofix Recalls Lapidus Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighSynthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility
FDA (Devices) · 2024-03-13