Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.
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 recall is classified as FDA Class II and involves a structural defect (instrument fracture) during a surgical procedure, which meets the rubric criteria for a Severe rating.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 22 units of the Triathlon Tritanium Patella Inserter. The product is a non-sterile instrument used in the Tritanium Knee System to implant the Tritanium Patella after the patellar bone has been prepared. The recall is due to a risk of instrument fracture during the implantation procedure.
The affected units are identified by Catalog No. 6541-3-530 and Lot Codes CTD2778 and CTD2779. These units were distributed in the United States, specifically in the states of Arizona, Florida, Kentucky, Louisiana, and New Jersey.
Healthcare providers and facilities should stop using the affected instruments immediately. Stryker Howmedica Osteonics Corp. is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 22
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. 6541-3-530. Lot Codes: CTD2778 and CTD2779.
Distribution
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