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
| Model / number | Product as published |
|---|---|
14-501660 | 2) Rod Reduce |
14-501661 | 3) 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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