Z-1378-2016 Class II Terminated
FDA device recall Z-1378-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Mar 22, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jul 19, 2016). Affected quantity: 140 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 20, 2016
- Initiation Date
- Mar 22, 2016
- Termination Date
- Jul 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140 units
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.
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.
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.
Code information
5450-800-311 Lot Number 0545410 5450-800-313 Lot Number 0555170
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1378-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026