CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Stryker, T2 Guidewire, Smooth-Tipped recalled

Stryker Howmedica Osteonics is recalling Stryker, T2 Guidewire, Smooth-Tipped, 2.2, distributed nationwide in the US. The recall was initiated on 21 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Quantity recalled147,838 units in 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-0880-2016
FDA event ID: 73156
Recalling firm: Stryker Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 21 Jan 2016
FDA classified: 24 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

21 Jan 2016	Recall initiated by company
24 Feb 2016	Classified by FDA	+34 days
2 Mar 2016	Published in enforcement report	+7 days

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

Reason for recall

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

Which lots are affected?

Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Where was it sold?

US Nationwide Distribution

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

17 other products · FDA event 73156

This product is part of a recall event; the main page for the event is Stryker, T2 Guidewire, Smooth-Tipped recalled.

Reported	Class	Recall	Company	Reason	Where
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Smooth-Tipped recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, Gamma3 K-Wire with Washer, . mm recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Ball-Tipped recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Fixation K-Wire 3 WCH coated recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Ball-Tipped recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Ball Tipped recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Ball-Tipped, mm recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 K-Wire, Sterile recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, Gamma Guide Pin, mm recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 K-Wire, mm recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 Guidewire, Ball-Tipped recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 K-Wire, 3.2x400mm, Recon recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, Metaizeau Intramedullary Pin recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, Gamma K-Wire, UNS-Thread recalled	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, Gamma K-Wire recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Packaging Defects	Nationwide
2 Mar 2016	CLASS II	Stryker, T2 K-Wire with washer recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Packaging Defects	Nationwide

More recalls from Stryker Howmedica Osteonics

All 86

Reported	Class	Recall	Company	Reason	Where
31 May 2017Device	CLASS II	Hoffmann LRF Safety Clip (Bone Transport Strut) recalled	Stryker Howmedica Osteonics	Other	Nationwide
18 Jan 2017Device	CLASS II	Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Other	Nationwide
28 Dec 2016Device	CLASS II	GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled	Stryker Howmedica Osteonics	Sterility	Nationwide
16 Nov 2016Device	CLASS II	LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled	Stryker Howmedica Osteonics	Device Malfunction	Nationwide
19 Oct 2016Device	CLASS II	Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled	Stryker Howmedica Osteonics	Other	NJ

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide