—#144573

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.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K020220
Affected lot / code info: 5450-800-311 Lot Number 0545410 5450-800-313 Lot Number 0555170

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

On 3/22/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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.

Timeline

Recall initiated: 2016-03-22
Posted by FDA: 2016-04-13
Terminated: 2016-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.