Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling 1,406 post-operative knee braces because they may fail to maintain a locked position, potentially causing loss of balance or undesired knee movement.
What this means for you
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: The recall involves a risk-of-harm product (potential loss of balance or undesired joint movement) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Corflex is recalling 1,406 units of the Contender Post-Op Knee Brace Lite (Model 75-7500-000). The device is indicated for range of motion control at the knee joint following various surgeries, including ACL, PCL, MCL, and LCL repairs, meniscal repairs, and total knee replacements.
The recall is due to a potential defect where the knee brace could fail to maintain the locked position. If this occurs, a loss of balance or undesired flexion/extension may happen at the affected knee joint. The affected units were distributed nationwide in the US and internationally to Canada, Taiwan, Singapore, and England.
Consumers should identify affected units by checking the Revision Code. All braces with a Revision Code beginning with AN, AP, AQ, AR, AS, AT, or AU should be returned to Corflex immediately for review. Additionally, braces with a Revision Code beginning with AM that were manufactured between September 1, 2015, and November 6, 2015, are also included in the recall.
The recalled product
- Product
- Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractu
- Manufacturer
- Corflex
- Affected units
- 1,406
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 (9)
- (1) all braces that begin with a Revision Code of AN
- AP
- AQ
- AR
- AS
- AT
- AU are to be returned to Corflex immediately for review
- 2015 and November 6
- 2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Corflex 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 7 products in this recall →Related recalls
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- HighCorflex Post-Operative Knee Brace Recalled for Potential Locking Failure
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