Agency classClass IIOur severity:High FDA (Devices)·Z-0578-2016·Announced 2016-01-13

Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

Corflex is recalling 10 units of the Brielle Ortho Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.

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: The recall involves a risk-of-harm product (potential loss of balance or undesired movement) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Corflex is recalling 10 units of the Brielle Ortho Contender Post-Op-Knee Brace Lite, Model 75-7500-087. This post-operative knee brace is indicated for range of motion control at the knee joint following various surgeries, including ACL, PCL, MCL, and LCL repairs, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

The recall is being issued because the knee brace could fail to maintain the locked position. If this failure occurs, a loss of balance or undesired flexion/extension may occur at the affected knee joint.

The affected units were distributed worldwide, including nationwide in the United States and internationally to Canada, Taiwan, Singapore, and England. Consumers should return all braces with a Revision Code beginning with AN, AP, AQ, AR, AS, AT, or AU immediately for review. Additionally, consumers should return all braces with a Revision Code beginning with AM that were manufactured between September 1, 2015, and November 6, 2015.

The recalled product

Product: BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 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…
Manufacturer: Corflex
Category: Medical Device — Orthopedic Brace
Hazard: mechanical-failure
loss-of-balance
Affected units: 10

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 →

Same manufacturer · Corflex

See all →

High
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
FDA (Devices) · 2016-01-13
High
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
FDA (Devices) · 2016-01-13
High
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
FDA (Devices) · 2016-01-13
High
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
FDA (Devices) · 2016-01-13
High
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
FDA (Devices) · 2016-01-13

Same hazard · mechanical failure