CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report
Stryker Neuro Drill Soft Touch Sterile recalled
Stryker Instruments Div. of Stryker is recalling Stryker Neuro Drill Soft Touch Sterile, distributed nationwide in the US. The recall was initiated on 22 May 2014 and the FDA has classified it as Class II.
Check your package
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-1776-2014
- FDA event ID
- 68331
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2014
- FDA classified
- 10 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 22 May 2014 | Recall initiated by company | |
| 10 Jun 2014 | Classified by FDA | +19 days |
| 18 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
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
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Where it was distributed
Worldwide Distribution - US (nationwide)
Questions about this recall
Is Stryker Neuro Drill Soft Touch Sterile recalled?
Yes. Stryker Instruments Div. of Stryker recalled Stryker Neuro Drill Soft Touch Sterile on 22 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1776-2014.
Why was it recalled?
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Which lots are affected?
Part Number 5820-107-40, Lot Number 13339017
Where was it sold?
Worldwide Distribution - US (nationwide)
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |