Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled
Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation and process failure (incomplete design history files) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet is recalling the A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve 3.2MM, Item Number 110017553. 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 product was distributed to the field without having completed design history files or design transfer activities. The recall involves 3 OUS of the product, specifically Lot Number 3286A.
The product was distributed worldwide, including US nationwide distribution in the states of NY, GA, FL, and MO, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and facilities should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Affected units
- 3
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 Number: 3286A (01)00887868135033(10)3286A
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 Plate Templates Due to Incomplete Design History
FDA (Devices) · 2020-06-17
Same hazard · documentation deficiency
See all →- 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
- ModerateBiomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve
FDA (Devices) · 2020-06-17
- ModerateBiomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files
FDA (Devices) · 2020-06-17