Stryker Recalls Spetzler Claw Tips Due to Incorrect Packaging Assembly
Stryker is recalling 140 Spetzler Claw Tips because they were packaged with the incorrect size Tip Sleeve Assembly, which may cause surgical delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states the risk is a surgical delay rather than direct injury or death, and no adverse events are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 140 units of Spetzler Claw Tip, Universal (5450-800-311) and Spetzler Open Angle Micro Claw Tip, Universal (5450-800-313). These bone cutting tips are removable attachments intended for use with the Sonopet Ultrasonic Handpiece. The recall was initiated because the products were packaged with the incorrect Tip Sleeve Assembly, which is the wrong size for the tips.
The affected units were distributed in the United States (AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA) and in the Netherlands. The specific lot numbers involved are 0545410 for the 5450-800-311 model and 0555170 for the 5450-800-313 model.
The risk to health is that if the Tip Sleeve Assembly does not fit the Spetzler Claw Tip, a surgical delay may occur while an alternate assembly is retrieved. No injuries or illnesses have been reported in the source text.
The recalled product
- 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 inte
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 5450-800-311 Lot Number 0545410 5450-800-313 Lot Number 0555170
Distribution
Related recalls
Same manufacturer · Stryker Instruments Div. of Stryker Corporation
See all →- HighStryker Triton Canister Scanning Labels Recalled Due to Color Variance
FDA (Devices) · 2022-07-27
- ModerateTriton Sponge System Software Instructions Updated for Proper Sponge Handling
FDA (Devices) · 2022-07-27
- HighSurgiCount+ System software error bypasses sponge tracking alerts
FDA (Devices) · 2022-07-27
- SevereStryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
FDA (Devices) · 2020-11-18
- ModerateStryker Neptune E-SEP Blade Electrode Recalled for Expired Product
FDA (Devices) · 2020-05-06
Same hazard · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18