Biomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects
Biomet is recalling 75 A.L.P.S. Foot Locking Calcaneus Plates because thread defects may cause screws to back out or shear, potentially requiring revision surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant that may require revision surgery and cause metal slivers, meeting the criteria for a Severe rating.
Plain-English summary
Biomet, Inc. is recalling 75 units of the A.L.P.S. Foot Locking Calcaneus Plate, Small-Right. This orthopaedic device is used by surgeons for bone fixation in fracture management and reconstructive surgeries. The recall involves specific part number 816209001 and lots 015840, 124980, 948210, P0059, P0076, or P0061.
The recall is due to a manufacturing defect where the thread location on one of the thread holes is offset from the axis of the predrill hole. This results in threads that are too deep on one side and too shallow on the other. Consequently, locking screws may fail to achieve proper purchase and back out of the plate, or the unevenly loaded threads may shear off, creating metal slivers.
The affected devices were distributed in the states of Texas, Maryland, Pennsylvania, New Jersey, North Carolina, Massachusetts, Arizona, Georgia, Florida, and Arkansas, as well as in Costa Rica and The Netherlands. Patients who have had this specific plate implanted should contact their orthopaedic surgeon to discuss the potential need for revision surgery to replace or remove the screw and/or plate.
The recalled product
- Product
- A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
- Manufacturer
- Biomet, Inc.
- Affected units
- 75
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 (6)
- Part Number: 816209001
- Lots: 015840
- 124980
- 948210 and P0059
- P0076
- or P0061 will be etched on the plate itself.
Distribution
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