Z-2357-2024Class II

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product...

Name: Z-2357-2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product...
Creator: Seaspine Orthopedics Corporation
Published: 2024-06-04
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2024-06-04 / Open, Classified / root cause: manufacturing process

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No on 2024-06-04. FDA classified it as Class II and gives the reason as "Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2357-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-04
Posted: 2024-07-15
Recalling firm: SeaSpine Orthopedics Corporation
Product: Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Product code: HWJ Awl
Reason for recall: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 100 units
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 codes and lots: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2357-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2357-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-15

Product code HWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)