DePuy Spine VIPER Polyaxial Screws Recalled for Potential Disassociation
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 recall is classified as FDA Class II and involves a structural defect in a spinal implant that could lead to device failure and significant injury, meeting the criteria for a Severe rating.
Plain-English summary
DePuy Spine, Inc. is recalling VIPER Polyaxial Screws, specifically the 5.5 10 X 70MM Tl model (Product Code: 1867-15-170). The recall involves 2 units of this spinal implant component. The distribution pattern includes nationwide distribution in the United States, specifically in Arizona, California, Florida, Hawaii, Illinois, Maryland, Michigan, Missouri, North Carolina, Tennessee, and Texas, as well as in Australia.
The recall is being conducted because polyaxial screws 8x 80 and larger may disassociate when inserted in the Ilium. Additionally, VIPER large diameter long screws have the potential for the screw shank to separate from the polyaxial head in high-torque circumstances. This defect poses a risk of device failure during surgical implantation.
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 source text does not specify a particular lot number, stating instead that the recall applies to 'All lots' for the identified product code.
The recalled product
- Product
- DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Affected units
- 2
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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