FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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
- Recalling firm
- Stryker 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.
- Status
- Terminated
- Initiated
- 2014-07-24
- Posted
- 2014-10-14
- Terminated
- 2017-06-08
- Reason
- 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
- 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 aminah.crawford@stryker.com.
- Quantity
- 484 units
- Distribution
- US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K131365"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28