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Recall Observatory FDA recall evidence

Device product

Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.

Z-1378-2016

March 22, 2016

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 73610
Status
Terminated
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-1378-2016

Official wording

Reason: The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.

Code information: 5450-800-311  Lot Number 0545410 5450-800-313  Lot Number 0555170

Distribution pattern: Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.