Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's 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 recall of knee implant with theoretical material degradation hazard from oxidation. No reported injuries or illnesses. Per the rubric, risk-of-harm products where injury has not been reported score 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Medialized Dome Patella Size #9 knee replacement components (Part Number 73-0910). The recall affects 192 units distributed in the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recall is due to the potential for elevated oxidation levels in the ultra-high-molecular-weight polyethylene (UHMWPE) raw material used in these components. Specifically, raw material over 5 years old is affected. Oxidation in UHMWPE can impact the material's properties.
The affected product lot numbers are X1WP, 6KE9, DL4V, HHPW, 1NL2, 4JHW, 0TNX, WN5E, 2EM2, 96N0, HW7E, T9NM, J72T, M73H, HM8H, MEM7, M8HN, and WL3Y. The product GTIN is 07613327050332.
The recalled product
- Product
- SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 192
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 (18)
- GTIN: 07613327050332 Lot Numbers: X1WP
- 6KE9
- DL4V
- HHPW
- 1NL2
- 4JHW
- 0TNX
- WN5E
- 2EM2
- 96N0
- HW7E
- T9NM
- J72T
- M73H
- HM8H
- MEM7
- M8HN
- WL3Y
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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