The Recall Desk
HighFDA (Devices)·Z-0575-2016·Announced 2016-01-13

Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

Corflex is recalling specific Post-Operative Knee Braces because they may fail to maintain a locked position, potentially causing loss of balance or unwanted 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 where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Corflex is recalling 6 units of the CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE, Model 75-7500-011. The recall affects specific units identified by Revision Codes beginning with AN, AP, AQ, AR, AS, AT, or AU, as well as units with Revision Codes beginning with AM that were manufactured between September 1, 2015, and November 6, 2015.

The recall is being issued because the knee brace could fail to maintain the locked position. If this occurs, a loss of balance or undesired flexion or extension may happen at the affected knee joint. The product was distributed nationwide in the United States and internationally to Canada, Taiwan, Singapore, and England.

Consumers should check the Revision Code on their brace. If the code matches the affected ranges listed above, they should return the brace to Corflex immediately for review.

The recalled product

Product
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 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 fr
Manufacturer
Corflex
Affected units
6

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 →