Z-0065-2015Class II

Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF...

Name: Z-0065-2015 Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2014-07-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2014-07-24 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2014-07-24. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0065-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-24
Posted: 2014-10-14
Terminated: 2017-06-08
Recalling firm: Howmedica Osteonics Corp
Product: 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 code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Stryker Orthopaedics sent an "Urgent Medical Device Removal" letter dated July 23, 2014 and Business Reply Form to their Branches/Agencies via e-mail on July 23, 2014 and their Hospital Risk Management was sent Notification Letters and Product Accountability Forms via FedEx (with return receipt) by July 24, 2014. The recall letter informed the customer of the problem. The customer was asked to return all affected products available to Stryker Osteosynthesis, c/o Paul Jahnke, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, REF: PFA #2014-101 or Contact Stryker's customer service and refer to PFA #2014-101 for returning the product to Stryker. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to: 1 (855) 251-3635 or email a copy to Aminah Crawford, Recall Coordinator at [email protected].
Quantity in commerce: 484 units
Distribution: US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0065-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0065-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-13

Product code HSB

K131365Class IIT2 Tibial Nailing SystemStryker Trauma AG / cleared 2013-10-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)