CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report

Stryker Wire Pass Drill Sterile recalled by Stryker Instruments Div. of

Stryker Instruments Div. of Stryker is recalling Stryker Wire Pass Drill 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

Lot, batch or date codesPart Number 5820-103-15, Lot Number 14004017

Quantity recalled246

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-1773-2014
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: Other Reasons
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.

Product as listed by the FDA

Stryker 1.5mm Wire Pass Drill 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)

Nationwide

Questions about this recall

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 5820-103-15, Lot Number 14004017

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 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

31 other products · FDA event 68331

This product is part of a recall event; the main page for the event is Stryker Acorn Bur Sterile recalled by Stryker Instruments Div. of.

Reported	Class	Recall	Company	Reason	Where
18 Jun 2014	CLASS II	Stryker Acorn Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Tapered Round Elite Bur Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Precision Neuro Drill Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Neuro Drill Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Egg Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Soft Touch Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Neuro Drill Soft Touch Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Zyphr Elite Round Fluted Bur Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Neuro Drill Soft Touch Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Zyphr Elite Round Fluted Bur Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Zyphr Elite Round Fluted Bur Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Neuro Drill Less Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Barrel Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Acorn Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Aggressive Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Soft Touch Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Round Fluted Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Zyphr Elite Round Fluted Bur Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker x Neuro Drill Soft Touch Sterile recalled	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Barrel Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Egg Bur Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Stryker Wire Pass Drill Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide
18 Jun 2014	CLASS II	Lindemann Drill Short Sterile recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	Nationwide

More recalls from Stryker Instruments Div. of Stryker

All 161

Reported	Class	Recall	Company	Reason	Where
27 Jul 2022Device	CLASS III	Triton Sponge System recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	Triton Canister System (finished part numbers FG recalled	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	SurgiCount+ System Application recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Device Malfunction	KS, ME
18 Nov 2020Device	CLASS II	Stryker Zyphr Disposable Cranial Perforator recalled	Stryker Instruments Div. of Stryker	Foreign Material	Nationwide
6 May 2020Device	CLASS II	Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	MI

Other Hip & Knee Implants recalls

All 3,097

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26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide