Device recall: Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of…
Class II FDA enforcement event 72727. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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,
Class II, in the words of FDA
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
Corflex started this device recall on 12 Nov 2015. The firm address in the FDA record is in Manchester, NH. FDA put the recall in Class II. FDA event 72727 has 7 product records. The first FDA enforcement report date is 13 Jan 2016. The record gives the status Terminated, with the termination date 29 Jun 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
Recalling firm
Corflex, Manchester, NH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0574-2016 | Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 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… | 1,406 units | Class II | Terminated | 13 Jan 2016 |
| Z-0575-2016 | 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… | 6 units | Class II | Terminated | 13 Jan 2016 |
| 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 knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high… | 4 units | Class II | Terminated | 13 Jan 2016 |
| Z-0577-2016 | ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 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… | 42 units | Class II | Terminated | 13 Jan 2016 |
| Z-0578-2016 | 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 femoral fractures, total knee replacements, and… | 10 units | Class II | Terminated | 13 Jan 2016 |
| Z-0579-2016 | ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 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… | 9 units | Class II | Terminated | 13 Jan 2016 |
| Z-0580-2016 | 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… | 80 units | Class II | Terminated | 13 Jan 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0574-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72727. https://recallregister.com/fda/ii/72727/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
- What quantity of product is in FDA event 72727?
- The event has 7 product records. The first record gives this quantity:
1,406 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.