Howmedica Osteonics Trident Knee Insert Recalled for Oxidation Risk
Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.
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: This is a medical device recall (FDA Class II) for a knee implant component where material degradation is theoretically possible due to raw material aging, but no injuries or adverse events have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Howmedica Osteonics Corp. is recalling Trident 0-degree polyethylene inserts, a component used in knee replacement surgery (Part Number 620-00-32J, Lot Number 29518001).
The recalled inserts were manufactured using ultra-high-molecular-weight polyethylene (UHMWPE) raw material that was over 5 years old at the time of production. Older raw material has the potential for elevated oxidation levels within the UHMWPE, which can affect the material's properties and the implant's performance.
The recall affects knee replacement systems distributed nationwide and internationally, including to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. This recall applies to products with Lot Number 29518001.
The recalled product
- Product
- HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
- 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 (1)
- GTIN: n/a Lot Numbers: 29518001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 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.
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