Knee replacement inserts recalled due to material oxidation risk
P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.
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 involving orthopedic implants where material oxidation presents theoretical risk to device performance; no injuries or hospitalizations reported.
Plain-English summary
This recall involves P7 32MM 10 Degree +4MM knee replacement inserts manufactured by Howmedica Osteonics Corp., part number 6302-6-307. The recalled lot numbers are 62112001 and 62120801. These inserts have been distributed nationwide and internationally.
The manufacturer identified that UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is over 5 years old can develop elevated oxidation levels. Oxidation within UHMWPE can impact the material's properties.
Patients who have received this implant should contact their surgeon or healthcare provider for guidance. The decision to remove or replace the implant should be made in consultation with your medical team.
The recalled product
- Product
- P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
- 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: 07613153076407 Lot Numbers: 62112001
- 62120801
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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