Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect
Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.
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 is classified as FDA Class II, and the source describes a functional failure (disassociation of a locking mechanism) during surgery, which poses a risk of harm, but does not explicitly report injuries or deaths.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 47 units of the Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile. This instrument is used to complement or replace standard instruments during the implantation of hip, knee, trauma, and upper extremity implants. The affected units were distributed nationwide to Florida, Indiana, Louisiana, North Carolina, Pennsylvania, Tennessee, and Utah.
The recall was initiated after reports that the secondary locking mechanism and its corresponding components disassociated from the handle assembly during surgery. An investigation revealed that the weld intended to hold the secondary locking mechanism together did not meet the weld size specified on the engineering drawing.
Healthcare facilities and consumers should stop using the affected products immediately. The specific catalog number is I-K3254TA00, and the affected lot numbers are F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099, and F7L16994.
The recalled product
- Product
- Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 47
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 (9)
- Catalog No: I-K3254TA00 Lot Nos: F6E13243
- F6L13864
- F6M14078
- F6S14667
- F6S14831
- F6W15444
- F6W15406
- F7C15943
- F7H16099 and F7L16994
Distribution
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