Teflon Tube — Class II medical device recall Z-0849-2014
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-02-05, distributed in GA, IL, KY, MI, MO, NJ, TN, UT…. Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer
| Recall number | Z-0849-2014 |
|---|---|
| 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 | 2013-11-07 |
| Classified | 2014-01-28 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-03-31 |
| Distributed | GA, IL, KY, MI, MO, NJ, TN, UT, VA |
| Quantity | 34 units |
| Reason classes | sterility, packaging |
| Lot numbers | K0432D3, K057298, K05ECF2, K05ECF3, K06C3B4 |
| Model numbers | 1806-0073S |
Product
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
Reason for recall
Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.
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-0849-2014. 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.