Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2016 - (Recall #: Z-1378-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 22, 2016

Date Posted: April 20, 2016

Recall Number: Z-1378-2016

Event ID: 73610

Reason for Recall:

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.

Status: Terminated

Product Quantity: 140 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated