SeaSpine Polyaxial Head Recalled Due to Potential Intraoperative Dislodgement
SeaSpine Orthopedics Corporation is recalling SeaSpine Polyaxial Head (REF Number: 41-3010) because the component may pop off the screw during 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with a high-risk hazard (component dislodgement during surgery) where injury has not yet been reported.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling SeaSpine Polyaxial Head (REF Number: 41-3010) due to a manufacturing error. This error may cause the polyaxial head to pop off from the screw intraoperatively following insertion.
The affected units include 796 units from lots AW199682G and AW199684G. Distribution is worldwide, including the United States (Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming), Chile, and Australia.
Healthcare providers should review their inventory for the affected lots and follow appropriate protocols for managing these devices.
The recalled product
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 796
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 (3)
- UDI: 10889981155117
- Affected Lots: AW199682G
- AW199684G.
Distribution
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