CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide recalled

Stryker Instruments Div. of Stryker is recalling 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide, distributed nationwide in the US. The recall was initiated on 4 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes50001 Lot numbers: 61303001, 61309001, 61310001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.

Quantity recalled5,800 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1040-2016
FDA event ID: 73172
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2016
FDA classified: 3 Mar 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

4 Feb 2016	Recall initiated by company
3 Mar 2016	Classified by FDA	+28 days
9 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

Where it was distributed

Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.

Nationwide Arizona California Colorado Connecticut Florida Georgia Iowa Kansas Massachusetts Michigan Minnesota Missouri New York Ohio Oklahoma Pennsylvania Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Which lots are affected?

50001 Lot numbers: 61303001, 61309001, 61310001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.

Where was it sold?

Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 73172

This product is part of a recall event; the main page for the event is (Stryker) AccuPlace Round Level Needle Guide recalled.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2016	CLASS II	(Stryker) AccuPlace Round Level Needle Guide recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
9 Mar 2016	CLASS II	(Stryker) AccuPlace Straight Level Needle Guide recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
9 Mar 2016	CLASS II	50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide

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15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
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