Reported Jun 14, 2017 · Terminated
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended…
Alphatec Spine, Inc.
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: Alphatec Spine, Inc. · 5830 El Camino Real · Carlsbad, CA · 92008-8816
Is this the product you have?
- Arsenal Spinal Fixation System, Set Screw, Part No. 47027
- Product UsageThe Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo)
- Lot codes and dates
79 of 79 codes
671949681640684646687843690206692720693064671948681641684646687843690206692705674136681642684647687847690210692718674137682061686374687847691848S1692719674431682060684645689847691848692855674432682062686372689847691849692855674433682063686375689849692597692706671950684429687839690127692597692864674429684430687839689848692364692910674430684432687840690207692598
- Amount recalled
- 16,959 units
Where it was sold
Why it was recalled
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
This product could cause temporary or reversible health problems — stop using it.
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