Biomet Recalls HipLOC CHS Plate/Lag Screw Introducer Due to Sizing Defect
Biomet is recalling 23 HipLOC CHS Plate/Lag Screw Introducers because some units are undersized and fail to accept the coupling screw.
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 source text describes a functional defect (undersized device) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 23 units of the HipLOC CHS Plate/Lag Screw Introducer. The recall was initiated after a complaint indicated that the device was undersized and would not accept the introducer coupling screw. The issue appears to be that not all parts manufactured to the Rev A drawing were properly reworked.
The affected products are identified by Catalog Number 35-000263 and Lot Numbers 1807188, 1807189, 1943563, and 2577847. These units were distributed in the United States to the states of Missouri, Utah, Arizona, Illinois, Pennsylvania, Kentucky, Michigan, North Carolina, New Jersey, Minnesota, and Georgia, as well as internationally to The Netherlands.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Biomet is the recalling firm responsible for managing the recall.
The recalled product
- Product
- HipLOC CHS Plate/Lag Screw Introducer
- Manufacturer
- Biomet, Inc.
- Affected units
- 23
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 (5)
- Catalog Number: 35-000263
- and Lot Number Identification: 1807188
- 1807189
- 1943563
- and 2577847.
Distribution
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07