Z-0877-2016Class II

Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm

Name: Z-0877-2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-01-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-01-21 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments on 2016-01-21. FDA classified it as Class II and gives the reason as "During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0877-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Posted: 2016-02-25
Terminated: 2017-06-08
Recalling firm: Howmedica Osteonics Corp
Product: Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Product code: MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Reason for recall: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
Quantity in commerce: 147,838 units in total
Distribution: US Nationwide Distribution
Product codes and lots: Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0868-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0869-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0870-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0871-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0872-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0873-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0874-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0875-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0876-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0877-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0878-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0879-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0880-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0881-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0882-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0883-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24
Z-0884-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code MAY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)