device · product 1 of 1
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.
- Recall number
- Z-0065-2015
- Initiated
- July 24, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 484 units
App-derived interpretation
Unknown
Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
Official device-enrichment evidence · Sourced
Mixed-up of materials/components
Inspect official wording and provenance
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.
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.