Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical instruments.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 10,537 units of the Triathlon Tibial Alignment Ankle Clamp, Catalog No. 6541-2-609. This non-sterile instrument is used by surgeons during Total Knee Arthroplasty (TKA) when using Stryker's Triathlon Total Knee System with extramedullary referencing. The recall covers all lot codes and the products were distributed nationwide.
The recall was initiated because the instruments may crack or fracture. This is a Class II recall, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.
Surgeons and medical facilities should stop using the affected instruments. Stryker Howmedica Osteonics Corp. is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing.…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 10,537
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 #6541-2-609 All lot codes
Distribution
Distributed nationwide across the United States.
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