—#143497

Product

Stryker, T2 Guidewire, Ball-Tipped, 3x800 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
510(k) numbers: K123604
Affected lot / code info: Catalog number 1806-0080S; 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 #143497. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.