Surgical Awl Recalled Due to Insufficient Weld Integrity
SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces 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: This is a Class II device recall involving a structural defect that creates risk of instrument failure under normal surgical use conditions. The rating reflects clear risk of harm with no reported injuries, meeting the High severity criterion for risk-of-harm products.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling the Meridian Angled Awl Fixed surgical instrument (Model RA2-003015). The recall involves 100 units with lot code UDI 10889981216368 (lot numbers TT0190H and TT0191H) that were distributed to healthcare facilities in 18 US states.
The company determined that the weld around the cap component of the instrument does not provide sufficient strength to withstand impaction forces during normal surgical use. This structural defect creates a risk that the instrument could fail during orthopedic surgical procedures.
The product was distributed to Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, and Arizona.
Affected healthcare facilities should discontinue use of the recalled units and contact SeaSpine Orthopedics Corporation for instructions regarding return, repair, or replacement of the affected instruments.
The recalled product
- Product
- Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 100
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: UDI 10889981216368 Lot Numbers TT0190H
- TT0191H
Distribution
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