Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
- Company
- Seaspine Orthopedics Corporation
- Recall Initiated
- June 4, 2024
- Posted
- July 15, 2024
- Recall Number
- Z-2357-2024
- Quantity
- 100 units
- Firm Location
- Carlsbad, CA
Reason for Recall
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Distribution
The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
Lot / Code Info
Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
Root Cause
Process design
Action Taken
On June 4, 2024, SeaSpine Orthopedics issued a "Urgent Medical Device Recall" Notification via E-Mail to affected consignees. SeaSpine Orthopedics ask consignees to take the following actions: We request that you return the affected part to SeaSpine s Carlsbad facility for evaluation and potential rework. To support your upcoming cases, a replacement Vu aPod Prime NM Angled Awl will be sent (PN: 33-40-1028). Additionally, please continue to utilize the loaner pool. Please use the attached label to return the inventory in your possession at your earliest convenience. Once the inventory has been returned, please acknowledge via DocuSign.