High FDA (Devices)·Z-1246-2018·Announced 2018-04-04

Stryker InterPulse Handpieces Recalled for Sterility Assurance Issues

Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in a medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling specific InterPulse Handpieces used for orthopedic purposes. The recall involves four product variations: InterPulse Handpiece with coaxial bone cleaning tip, InterPulse Handpiece with Coaxial High Flow Tip, InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, and InterPulse Irrigation Only Handpiece with Fan Spray Tip. A total of 5,988 units are affected.

The reason for the recall is a lack of sterility assurance, as bioburden levels were found to be higher than internal acceptable rates. The affected products were distributed in all 50 U.S. States and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and the United Kingdom.

Healthcare providers and facilities should identify the affected units by checking the product numbers and lot numbers listed in the official recall notice. Users should stop using the affected handpieces and contact Stryker for instructions on return or replacement.

The recalled product

Product: 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip,
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Orthopedic Handpieces
Hazard: sterility-assurance
bioburden
Affected units: 5,988

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 (15)

1. Lot Numbers: 17283012
17284012
17286012
2. Lot Numbers: 17278012
17280012
17282012
17283012
17285012
17289012
17292012
3. Lot Number: 17279012
4. Lot Number: 17284012 UDI: (01)4546540861641
(01)4546540861764
(01)4546540861818
(01)4546540144300

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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Same hazard · sterility assurance