CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Cypher MIS Screw System, Biomet Spine Parsippany, NJ recalled by Ebi

Ebi is recalling Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054, distributed nationwide in the US. The recall was initiated on 13 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021

Quantity recalled427 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-2214-2013
FDA event ID: 66098
Recalling firm: Ebi, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2013
FDA classified: 17 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

13 Aug 2013	Recall initiated by company
17 Sep 2013	Classified by FDA	+35 days
25 Sep 2013	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

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Product as listed by the FDA

Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

Where it was distributed

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

Nationwide Maryland Mississippi North Carolina Ohio Pennsylvania South Carolina Texas

Questions about this recall

Is Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054 recalled?

Yes. Ebi recalled Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054 on 13 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2214-2013.

Why was it recalled?

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Which lots are affected?

14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021

Where was it sold?

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

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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1 May 2024Device	CLASS II	Biomet SpinalPak Non-invasive Spine Fusion Stimulator recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	48" Lead Wires, Replacement recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
14 Jan 2015Device	CLASS II	Cypher MIS Screw System-The system includes screws recalled by Ebi	Ebi	Other	9 states

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