Knee Implant Tibial Inserts Recalled for Sterile Packaging Breach
Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.
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: FDA Class II device with potential compromise to sterile packaging of an implantable orthopedic component. A breach in sterile packaging of a surgical implant poses a significant risk of infection, though no illnesses or injuries have been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain lots of the NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM (tibial inserts) due to potential packaging breaches. The affected product lots are identified by Part No. 5537-G-513-E and Lot No. 9M3A91 or EV0DV0.
The recall involves 37 units distributed nationwide in the United States and 10 units distributed internationally to Australia, Canada, Chile, Colombia, Korea, and Japan. The issue involves potential breaches of the inner blister and outer sterile packaging of the product.
Patients and healthcare providers who may have received these recalled devices should contact Howmedica Osteonics Corp. immediately to determine if their devices are affected and for instructions on replacement or return.
The recalled product
- Product
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- Manufacturer
- 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 (5)
- Part No. 5537-G-513-E
- GTIN: 07613327287813
- Lot No. 9M3A91
- EV0DV0
- Expiration Date: 10/07/2028.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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