Z-1378-2016Class II

Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The...

Name: Z-1378-2016 Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-03-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-03-22 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2016-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1378-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Posted: 2016-04-13
Terminated: 2016-07-19
Recalling firm: Stryker Corp.
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.
Product code: LFL Instrument, Ultrasonic Surgical
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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: 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 [email protected]
Quantity in commerce: 140 units
Distribution: 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.
Product codes and lots: 5450-800-311 Lot Number 0545410 5450-800-313 Lot Number 0555170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1378-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13

Product code LFL

K020220UnclassifiedUltrasonic Straight/ultrasonic Knife/ultrasonic Ring CurretteSynergetics, Inc. / cleared 2002-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)