Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could 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: This is an FDA Class II medical device recall with potential material degradation in a joint implant. No injuries or hospitalizations have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, corresponding to score 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT components (Part Number: 6302-6-107) intended for use in knee replacement procedures. The recall affects components manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is over 5 years of age. Such aged material has the potential for elevated levels of oxidation, which can negatively impact the material's properties and structural integrity.
The recalled components were distributed nationwide and internationally to numerous countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. As of January 25, 2024, distribution was additionally identified in Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The affected lot numbers are 61311701 and 62122001, with GTIN 07613153076155. Patients and healthcare providers who may have received these components should contact Howmedica Osteonics Corp. with questions regarding this recall.
The recalled product
- Product
- P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
- 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 (2)
- GTIN: 07613153076155 Lot Numbers: 61311701
- 62122001
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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