CLASS II Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

MectaLIF Anterior - Lag Plate Flush H14 recalled by Medacta Usa

Medacta Usa is recalling MectaLIF Anterior - Lag Plate Flush H14, distributed in Arizona, Georgia, Idaho, Texas, Virginia. The recall was initiated on 8 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 07630345732309, All Lot Numbers

Quantity recalled44 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-1402-2023
FDA event ID: 91947
Recalling firm: Medacta Usa, Memphis, TN
Classification: Class II
Status: Completed
Recall initiated: 8 Mar 2023
FDA classified: 19 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

8 Mar 2023	Recall initiated by company
19 Apr 2023	Classified by FDA	+42 days
26 Apr 2023	Published in enforcement report	+7 days

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

Reason for recall

There is a potential for breakage of the small screw used to affix the anti-backout plate.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

Where it was distributed

US: ID, TX, GA, VA, AZ

Arizona Georgia Idaho Texas Virginia

Questions about this recall

Is MectaLIF Anterior - Lag Plate Flush H14 recalled?

Yes. Medacta Usa recalled MectaLIF Anterior - Lag Plate Flush H14 on 8 Mar 2023. The recall is Class II and its status is Completed. Recall number Z-1402-2023.

Why was it recalled?

There is a potential for breakage of the small screw used to affix the anti-backout plate.

Which lots are affected?

UDI/DI 07630345732309, All Lot Numbers

Where was it sold?

US: ID, TX, GA, VA, AZ

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.

More recalls from Medacta Usa

All 17

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Short Monobloc Stem Broaches, Size recalled by Medacta Usa	Medacta Usa	Device Malfunction	Nationwide
26 Apr 2023Device	CLASS II	MectaLIF Anterior - Lag Plate Flush H16 recalled by Medacta Usa	Medacta Usa	Device Malfunction	5 states
26 Apr 2023Device	CLASS II	MectaLIF Anterior - Lag Plate Flush H12 recalled by Medacta Usa	Medacta Usa	Device Malfunction	5 states
26 Apr 2023Device	CLASS II	MectaLIF Anterior - Lag Plate Flush H18 recalled by Medacta Usa	Medacta Usa	Device Malfunction	5 states
26 Apr 2023Device	CLASS II	MectaLIF Anterior - Antibackout Lag Cover recalled by Medacta Usa	Medacta Usa	Device Malfunction	5 states

Other Spinal Implants recalls

All 1,157

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9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
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9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide