Daytona Small Stature Locking Caps recalled for manufacturing defects
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
What this means for you
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: This is a Class II medical device recall involving a manufacturing defect that impairs component mating in an orthopedic implant system, creating risk of device failure. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling 92 Daytona Small Stature CoCr Locking Cap devices (Model 79-0002, 4.5mm, T25 drive) due to manufacturing defects. The defects affect the ability of the locking cap to properly mate with other components in the orthopedic implant system.
The affected devices include lot numbers MM1002742E and MM1003065E (UDI 10889981185640). These components are used in orthopedic surgical procedures.
The recalled devices were distributed nationwide in California, Colorado, Florida, Georgia, Pennsylvania, Texas, and Virginia. A total of 92 units are affected.
If you have received or been implanted with one of these devices, contact SeaSpine Orthopedics Corporation or your healthcare provider immediately to determine whether the device should be replaced or your surgical status reviewed.
The recalled product
- Product
- Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Hazard
- manufacturing-defect
- component-mating-failure
- implant-failure-risk
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 (2)
- Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E
- MM1003065E
Distribution
Distributed nationwide across the United States.
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