DePuy Spine VIPER Polyaxial Screws Recalled for Potential Component Separation
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
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 agency classified this as a Class II recall involving a structural defect in a spinal implant, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
DePuy Spine, Inc. is recalling VIPER Polyaxial Screws, specifically the 5.5 10x100mm model (Product Code: 1867-15-199). The recall involves 10 units distributed nationwide in the United States and in Australia.
The recall is due to a potential mechanical defect where the screw shank may separate from the polyaxial head. This risk is associated with high-torque circumstances, such as when inserting polyaxial screws 8x 80 and larger into the ilium.
Healthcare providers and patients who have received these specific spinal implant components should contact DePuy Spine, Inc. for further instructions on how to proceed.
The recalled product
- Product
- DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Affected units
- 10
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)
- All lots
Distribution
Part of a larger recall action
This product is one of 9 recalled by DePuy Spine, Inc. 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.
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