Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product 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 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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057
- 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. 47027 Product 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 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).
Product Codes/Lot Numbers:
671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2249-2017
Related Recalls
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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.