The Recall Desk
HighFDA (Devices)·Z-0576-2016·Announced 2016-01-13

Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

Corflex is recalling specific models of the Hailey Ortho Contender Post-Op Knee Brace because they may fail to maintain a locked position, risking loss of balance or unwanted joint 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 is classified as FDA Class II and involves a risk of injury (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 for risk-of-harm products without reported injury.

Plain-English summary

Corflex is recalling 4 units of the Hailey Ortho Contender Post-Op Knee Brace, Model 75-7500-038. 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 product was distributed nationwide in the United States and internationally to Canada, Taiwan, Singapore, and England.

The recall was initiated because the knee brace could fail to maintain the locked position. If the brace fails to lock, a loss of balance or undesired flexion or extension may occur at the affected knee joint. This device is indicated for range of motion control following various knee surgeries, including ACL, PCL, MCL, and LCL repairs, meniscal repairs, and total knee replacements.

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 agency has classified this recall as Class II.

The recalled product

Product
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 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 fract
Manufacturer
Corflex
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 (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 →