CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report

Meridian Angled Awl Fixed Angled Awl Fixed recalled

Seaspine Orthopedics is recalling Meridian Angled Awl Fixed Angled Awl Fixed, distributed in 18 states. The recall was initiated on 4 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Quantity recalled100 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2357-2024
FDA event ID: 94872
Recalling firm: Seaspine Orthopedics, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Jun 2024
FDA classified: 15 Jul 2024
Reported: 24 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

4 Jun 2024	Recall initiated by company
15 Jul 2024	Classified by FDA	+41 days
24 Jul 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Colorado Florida Georgia Illinois Indiana Michigan Minnesota Missouri Montana Nevada Pennsylvania South Dakota Tennessee Texas Virginia Washington

Questions about this recall

Is Meridian Angled Awl Fixed Angled Awl Fixed recalled?

Yes. Seaspine Orthopedics recalled Meridian Angled Awl Fixed Angled Awl Fixed on 4 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2357-2024.

Why was it recalled?

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

Which lots are affected?

Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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