Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2014 - (Recall #: Z-0065-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

Product Classification:

Class II

Date Initiated: July 24, 2014

Date Posted: October 22, 2014

Recall Number: Z-0065-2015

Event ID: 69065

Reason for Recall:

Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.

Status: Terminated

Product Quantity: 484 units

Code Information:

Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019

Distribution Pattern:

US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated