Total knee prosthesis recalled for excess ethylene oxide residuals
American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.
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 Class II recall involves a permanent implant with chemical residuals exceeding established safety standards (ISO 10993-7). While no illnesses or injuries have been reported, the risk-of-harm from prolonged exposure to ethylene oxide and ethylene chlorohydrin residuals in an implant that remains in the body justifies a High severity rating.
Plain-English summary
American Contract Systems Inc is recalling 272 units of its TOTAL KNEE knee prosthesis (Catalog Number LMTK17AP) distributed nationwide. The recall affects units with lot numbers 645231, 976241, and 918241.
The cast padding component of the prosthesis contains elevated levels of ethylene oxide and ethylene chlorohydrin residues. These residue levels exceed the safe limits established by the ANSI/AAMI/ISO 10993-7 standard for implants that remain in the body permanently.
Patients who received these implants should contact their healthcare provider or orthopedic surgeon to discuss whether this recall affects them and what action, if any, they should take.
The recalled product
- Product
- TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 272
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)
- UDI-DI: 00191072192172 LOT#"s: 645231 976241 918241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems Inc 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 39 products in this recall →Related recalls
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