FDA Devices recall · Reported April 20, 2016
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.
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 Sl…
Stryker Instruments Div. of Stryker Corporation recalled Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Univers… - a moderate-severity action.
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Univers… was recalled by Stryker Instruments Div. of Stryker Corporation in April 20, 2016. Reason: The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included i…. Check the official notice for the remedy. Verify recall #Z-1378-2016 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included i….
- Moderate
- severity level
- 140 units
- affected scope
- Class II
- classification
- April 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1378-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1378-2016 |
| Date reported | April 20, 2016 |
| Date initiated | March 22, 2016 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1378-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026