Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise
Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.
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 potential compromise of the sterile barrier for a medical device, which poses a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 34 units of sterile Teflon tubes (Catalog Number 1806-0073S) used in T2 nailing systems. The recall involves specific lots (K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3) distributed in the United States.
The recall was initiated after Stryker laboratory testing revealed that the seal integrity of the outer sterile pouch may be compromised for these specific lots. The product is intended to support the exchange of guide wires in T2 Tibial, Femoral, Ankle, and Humerus Nailing Systems.
The affected units were distributed in the states of Georgia, Illinois, Kentucky, Michigan, Missouri, New Jersey, Tennessee, Utah, and Virginia. Healthcare facilities and consumers should stop using the affected lots and contact Stryker for further instructions.
The recalled product
- 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…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 34
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 (5)
- Catalog Number 1806-0073S Lot Code K06C3B4
- K05ECF3
- K05ECF2
- K057298
- K0432D3
Distribution
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