Z-0575-2016Class II

CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for...

Name: Z-0575-2016 CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for...
Creator: Corflex
Published: 2015-11-12
License: https://open.fda.gov/license/

Thuasne, LLC / initiated 2015-11-12 / Terminated / root cause: manufacturing process

FDA source

Corflex began a recall of 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... on 2015-11-12. FDA classified it as Class II and gives the reason as "Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0575-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-12
Posted: 2016-01-04
Terminated: 2016-06-29
Recalling firm: Thuasne, LLC
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 fractures, total knee replacements, and high tibial osteotomies. 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 fractures, total knee replacements, and high tibial osteotomies.
Product code: ITQ Joint, Knee, External Brace
Reason for recall: Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Corflex notified customers on November 12, 2015, initially via phone. On December 9, 2015, a follow-up letter dated December 8, 2015, was issued via email with read receipt. Customers have been instructed to return all product to Corflexs Manchester, NH manufacturing facility. This removal includes product that is new, in use and no longer in service. Customers have been provided instructions on how to contact our Customer Service department to initiate the return process and generate a Returns Material Authorization. UPS Call Tags are also being issued to facilitate the return of braces at no cost to the customer. Contact Corflex at [email protected] or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
Product codes and lots: (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; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0575-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0574-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0575-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0576-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0577-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0578-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0579-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04
Z-0580-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

Product code ITQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)