Meridian recallZ-2357-2024 · Seaspine Orthopedics Corporation · initiated Jun 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seaspine Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2357-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2024
- Posted by the FDA
- Jul 15, 2024
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 100 units
- Product code
- HWJ
- 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
Product description
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Code information (models, lots, serial numbers)
Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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