CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report

MaxAn and fixed screws, used recalled by Biomet Spine

Biomet Spine is recalling MaxAn and fixed screws, used in the MaxAn Anterior Cervical Plate System, distributed in Florida, Missouri, New York. The recall was initiated on 29 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesP/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

Quantity recalled17 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-0203-2016
FDA event ID: 72312
Recalling firm: Biomet Spine, Broomfield, CO
Classification: Class II
Status: Terminated
Recall initiated: 29 Sep 2015
FDA classified: 3 Nov 2015
Reported: 11 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Spinal Implants

Timeline

29 Sep 2015	Recall initiated by company
3 Nov 2015	Classified by FDA	+35 days
11 Nov 2015	Published in enforcement report	+8 days

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

Reason for recall

The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

Where it was distributed

US Distribution to the states of : NY, MO, and FL

Florida Missouri New York

Questions about this recall

Why was it recalled?

The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

Which lots are affected?

P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

Where was it sold?

US Distribution to the states of : NY, MO, and FL

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 26 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 Biomet Spine

All 14

Reported	Class	Recall	Company	Reason	Where
6 Apr 2016Device	CLASS II	X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System recalled	Biomet Spine	Labeling Errors	Nationwide
16 Sep 2015Device	CLASS II	Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft recalled	Biomet Spine	Foreign Material	Nationwide
16 Sep 2015Device	CLASS II	Biomet Parsippany, NJ recalled by Biomet Spine	Biomet Spine	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	Polaris 4.75 TI Spinal System, Closed MAS recalled by Biomet Spine	Biomet Spine	Potency & Assay	Nationwide
29 Apr 2015Device	CLASS II	Lineum HF Torque Handle Limit (Lineum) recalled by Biomet Spine	Biomet Spine	Other	Nationwide

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