Stryker T2 Humerus System Teflon Tube Recalled Due to Material Embrittlement
Stryker Howmedica Osteonics is recalling 100 units of the T2 Humerus System Teflon Tube because a manufacturing error caused the tube material to become embrittled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect (embrittlement) in a medical device used for fracture treatment, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 100 units of the Stryker T2 Humerus System Teflon Tube, sterile (REF 1806-0073S, Lot Code 123596). The Teflon Tube is an optional instrument used with the T2 Nailing System to exchange guide wires during the treatment of complex fractures in humeral, femoral, tibial, and ankle applications.
The recall was initiated because a manufacturing error during the production of the affected lot led to embrittlement of the tube material. This defect could potentially affect the structural integrity of the instrument during use.
The affected units were distributed worldwide, including nationwide in the United States (specifically in AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR, and TX) and in Australia, Canada, France, Spain, and the United Kingdom. Healthcare providers and facilities should stop using the affected Teflon Tubes and contact Stryker Howmedica Osteonics for further instructions on the recall.
The recalled product
- Product
- Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No: 1806-0073S Lot Code:123596
Distribution
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