Recalls / —

—#143495

Product

Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

FDA product code

MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern

US Nationwide Distribution

Timeline

Recall initiated

2016-01-21

Posted by FDA

2016-02-25

Terminated

2017-06-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #143495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.