Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: 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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers 695621 696252 697128 698437 700943 7689801 695622 696253 697129 698438 700944 7689802 695623 696254 697130 698439 700945 7689803 695624 696255 697131 698440 701393 7689804 695625 696256 697520 698441 701394 695626 696257 697521 698442 701395 695627 696258 697522 700611 701396 696124 696558 697523 700612 701397 696125 696574 697524 700613 701398 696126 696575 698433 700614 701399 696127 696576 698434 700615 701400 696128 696577 698435 700941 701401 696251 697127 698436 700942 701851 7878901 7829602 7766302 7766301
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Alphatec Spine, Inc.
- Reason for Recall:
- Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: 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).
Product Codes/Lot Numbers:
Lot Numbers 695621 696252 697128 698437 700943 7689801 695622 696253 697129 698438 700944 7689802 695623 696254 697130 698439 700945 7689803 695624 696255 697131 698440 701393 7689804 695625 696256 697520 698441 701394 695626 696257 697521 698442 701395 695627 696258 697522 700611 701396 696124 696558 697523 700612 701397 696125 696574 697524 700613 701398 696126 696575 698433 700614 701399 696127 696576 698434 700615 701400 696128 696577 698435 700941 701401 696251 697127 698436 700942 701851 7878901 7829602 7766302 7766301
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0592-2017
Related Recalls
Complaints have been received regarding post-operative implant collapse.
Due to reports of intraoperative graft bolt implantation breakages.
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.