Stryker T2 Tibia System Nail Insertion Sleeve — Class II medical device recall Z-0065-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-10-22, distributed nationwide. Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner dia
| Recall number | Z-0065-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2014-07-24 |
| Classified | 2014-10-13 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2017-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 484 units |
| Reason classes | labeling |
| Lot numbers | K019A3C, K031467, K031468, K032811, K032812, K03E8AD, K06AAA8, K074529, K07F95F, K083672 |
| Model numbers | 08-11, 08-13, 1806-1406S, 1806-1407S |
| Expiration dates | 2019-03-31 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0065-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.