Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded 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 a risk-of-harm medical device (knee implant) where the hazard (material oxidation) is theoretical with no reported illnesses or injuries, meeting the rubric criterion for a High severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11, a component designed for knee replacement surgery.
The recalled product may have been manufactured using UHMWPE (ultra-high molecular weight polyethylene) raw material over 5 years of age. Material of this age can develop elevated oxidation levels, which may impact material properties and affect implant performance.
The recall affects 4 units with lot numbers LT28 and 4TXX (Part Number 73-2110). The affected units were distributed nationwide and to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recalled product
- Product
- SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 4
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: 07613327033816 Lot Numbers: LT28
- 4TXX
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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