CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report
Contender Post-op-knee Brace Full Foam recalled by Corflex
Corflex is recalling Contender Post-op-knee Brace Full Foam, distributed nationwide in the US. The recall was initiated on 12 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0580-2016
- FDA event ID
- 72727
- Recalling firm
- Corflex, Manchester, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2015
- FDA classified
- 4 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 12 Nov 2015 | Recall initiated by company | |
| 4 Jan 2016 | Classified by FDA | +53 days |
| 13 Jan 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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,
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 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 fractures, total knee replacements, and high tibial osteotomies.
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
Questions about this recall
Is Contender Post-op-knee Brace Full Foam recalled?
Yes. Corflex recalled Contender Post-op-knee Brace Full Foam on 12 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0580-2016.
Why was it recalled?
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,
Which lots are affected?
(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
Where was it sold?
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Corflex
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ortho Spec Grp Contender Post-op-knee Brace Lite recalled by Corflex | Corflex | Device Malfunction | Nationwide |
| Device | CLASS II | Hailey Ortho Contender Post-op-knee Brace recalled by Corflex | Corflex | Device Malfunction | Nationwide |
| Device | CLASS II | CT Ortho Contender Post-op-knee Brace Lite recalled by Corflex | Corflex | Device Malfunction | Nationwide |
| Device | CLASS II | Adv Ortho Contender Post-op-knee Brace Lite recalled by Corflex | Corflex | Device Malfunction | Nationwide |
| Device | CLASS II | Contender Post-Op Knee Brace Lite recalled by Corflex | Corflex | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |