Knee replacement poly insert recalled due to material oxidation risk
Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.
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 medical device recall with no reported illnesses or injuries. The hazard is theoretical material property degradation in a load-bearing orthopedic implant; per the rubric, recalls with potential harm but no reported injuries are classified as High (3).
Plain-English summary
Howmedica Osteonics Corp. is recalling certain TRIDENT 0-degree poly inserts (Part Number 620-00-28J, Lot 38059601) used in knee replacement surgeries. The recall affects devices distributed nationwide and internationally, including to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and other countries. As of January 2024, distribution was expanded to Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recall was issued because UHMWPE raw material over 5 years of age may develop elevated oxidation levels. Oxidation can affect the material properties of the polyethylene insert.
Healthcare providers and patients with this device should consult their physician about the recall. No illnesses or injuries have been reported.
The recalled product
- Product
- HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
- 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: 38059601
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.
See all 58 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
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Same hazard · polymer oxidation
See all →- HighKnee replacement implant recalled due to potential material degradation
FDA (Devices) · 2024-02-07
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