Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Sterility Risk
Stryker is recalling 5,800 AccuPlace Drace Stereotaxic Needle Guides due to a potential breach in sterility caused by packaging damage.
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 source text describes a 'potential' for sterility breach without reporting any actual illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 5,800 units of the 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide. This medical device assists users with inserting a needle at a predetermined angle for computer tomography. The recall is classified as Class II by the FDA.
The recall was initiated after an evaluation of the product packaging determined that there is a potential for the product to cause damage to the packaging. This damage could create a possible breach in sterility. The affected devices were distributed nationwide, including in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.
Affected devices have lot numbers 61303001, 61309001, 61310001, and 61404006. Devices distributed between May 1, 2013, and May 31, 2014, are labeled with Inrad's name and product number. Devices distributed between June 20, 2014, and December 3, 2015, are labeled with Stryker's name and product number. Healthcare facilities should stop using these devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 5,800
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 (3)
- 50001 Lot numbers: 61303001
- 61309001
- 61310001
Distribution
Part of a larger recall action
This product is one of 4 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.
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