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Open, Classified

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

FDA Recall Z-2357-2024 · Posted 2024-07-15

Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeHWJ
Date Initiated2024-06-04
Product Quantity100 units

Reason for Recall

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

Firm 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.

Root Cause

Process design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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