Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
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 is a documentation and process failure (incomplete design history files) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet is recalling 78 units of the A.L.P.S. Proximal Humerus Plating System Proximal Humerus Plate Template 90MM (Item Number: 110025471). The product is intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
The recall was initiated because the devices were distributed to the field without having completed design history files or design transfer activities. The affected units are identified by Lot Numbers 429698 and 452448.
The recalled products were distributed worldwide, including in the United States (specifically New York, Georgia, Florida, and Missouri) and in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Affected units
- 78
Distribution
Part of a larger recall action
This product is one of 22 recalled by Biomet 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 22 products in this recall →Related recalls
Same manufacturer · Biomet
See all →- HighBiomet Outer Sheath Recalled Due to Failed Sterilization Validation Testing
FDA (Devices) · 2020-06-24
- HighBiomet Recalls Screw Instrument Tray Due to Sterilization Validation Failure
FDA (Devices) · 2020-06-24
- ModerateBiomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files
FDA (Devices) · 2020-06-17
- ModerateBiomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies
FDA (Devices) · 2020-06-17
- ModerateBiomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
FDA (Devices) · 2020-06-17
Same hazard · documentation deficiency
See all →- LowMindray Panorama and Telemetry Monitoring System Operator's Manuals Recalled
FDA (Devices) · 2026-10-14
- LowMindray BeneVision Telemetry Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMyChai Chai Tea Concentrate Recalled for Missing Production Records
FDA (Food) · 2024-11-13
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01
- ModerateGetinge Washer Disinfector models recalled for inadequate installation documentation
FDA (Devices) · 2022-05-25
Similar recalls
- ModerateMiami Device Solutions Recalls Right Proximal Humerus Plates Due to Identification Error
FDA (Devices) · 2019-12-11
- SevereBiomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects
FDA (Devices) · 2015-07-15
- ModerateSynthes Humerus Plates Recalled for Incorrect Part Number Labeling
FDA (Devices) · 2015-10-21
- HighZimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk
FDA (Devices) · 2020-03-04
- HighBiomet Recalls A.L.P.S. Clavicle Plating System Due to Drill Fracture Risk
FDA (Devices) · 2021-01-27
- HighToby Orthopaedics Recalls PANTERA Proximal Humerus Fracture Plate System
FDA (Devices) · 2019-12-11