DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation
DePuy Spine is recalling VIPER polyaxial screws because the 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. The hazard involves the structural separation of a spinal implant component, which poses a significant risk of injury or device failure during or after surgery, meeting the criteria for a Severe rating.
Plain-English summary
DePuy Spine, Inc. is recalling 23 units of VIPER Polyaxial Screws (Product Code 1867-15-999). The recall covers the VIPER Poly Screw 5.5 9 X100MM Tl, a spinal implant component.
The recall was initiated because polyaxial screws 8x 80 and larger may disassociate when inserted into 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.
The affected units were distributed worldwide, including nationwide in the United States (specifically in AZ, CA, FL, HI, IL, MD, MI, MO, NC, TN, and TX) and in Australia. All lots are affected. Healthcare providers should contact DePuy Spine for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 23
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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