Reported Nov 23, 2016 · Terminated
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is…
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. 47127
- Product UsageUsage: The 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 ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo)
- Lot codes and dates
- Lot Numbers
73 of 73 codes
6956216962526971286984377009437689801695622696253697129698438700944768980269562369625469713069843970094576898036956246962556971316984407013937689804695625696256697520698441701394695626696257697521698442701395695627696258697522700611701396696124696558697523700612701397696125696574697524700613701398696126696575698433700614701399696127696576698434700615701400696128
- Lot Numbers
- Amount recalled
- 16,972 units
Where it was sold
- Nationwide
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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