Reported Sep 25, 2013 · Terminated

Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal…

Ebi, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ebi, Llc · 100 Interpace Pkwy · Parsippany, NJ · 07054-1149

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
14-5016602) Rod Reduce
14-5016613) Counter Torque
14-501662
Lot codes and dates
  • 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
Amount recalled
427 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 11, 2015 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.