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

FDA device recall Z-2357-2024 · posted 2024-07-15 · Open, Classified

Recall details

Recalling firm

SEASPINE ORTHOPEDICS CORPORATION

Reason for recall

Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

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.

Root cause

Process design

Status

Open, Classified

Product code

HWJ

Quantity affected

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, C

Date initiated

2024-06-04

Date posted

2024-07-15

Location

Carlsbad, CA