FDA Device recall Z-0576-2016
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the kne…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the kne… by Corflex, citing 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,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0576-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-12 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Corflex |
| Distribution | US |
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 fractures, total knee replacements, and high tibial osteotomies.
Reason
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,
Identifiers
| code_info | (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately…(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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0576-2016%22
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