Stryker PROFESS Registration Kit Recalled for Expiration Date Issues
Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 specific defect is a labeling/expiration date issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 65 units of the Stryker PROFESS Registration Kit. The recall is due to the product being shipped proximate to or past the expiration date listed on the product label.
The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable. The affected lot number is 202085 and the Stryker Product Number is 6001-420-000.
The affected units were distributed nationwide to the states of CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX. Healthcare facilities and consumers should stop using the affected kits and contact Stryker for further instructions.
The recalled product
- Product
- Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 65
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)
- Lot #202085 Stryker Product Number: 6001-420-000
Distribution
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