Spetzler Claw Tip — Class II medical device recall Z-1378-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-04-20, distributed in AZ, CA, CO, CT, IL, IN, MD, MI…. The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in
| Recall number | Z-1378-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2016-03-22 |
| Classified | 2016-04-13 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-07-19 |
| Distributed | AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, VA, WA, WI |
| Countries outside the US | NL |
| Quantity | 140 units |
| Lot numbers | 0545410, 0555170, 5450-800-313 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1378-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.