CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report
Stryker, T2 Guidewire, Ball-Tipped recalled
Stryker Howmedica Osteonics is recalling Stryker, T2 Guidewire, Ball-Tipped, 3, 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
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-0878-2016
- 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, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Stryker, T2 Guidewire, Ball-Tipped, 3 recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker, T2 Guidewire, Ball-Tipped, 3 on 21 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0878-2016.
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 1806-0085S; 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 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.
More recalls from Stryker Howmedica Osteonics
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) recalled | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
| Device | CLASS II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
| Device | CLASS II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |