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ModerateClass IITerminated

FDA Devices recall · Reported January 13, 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 high tibial osteotomies.

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,

Recall #
Z-0577-2016
Affected scope
42 units
Initiated
November 12, 2015
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Corflex recalled ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee… — a moderate-severity action.

ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee… was recalled by Corflex in January 13, 2016. Reason: Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension m…. Check the official notice for the remedy. Verify recall #Z-0577-2016 with the FDA Devices before acting.

The recall

Corflex issued this moderate-severity FDA Devices recall — Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension m….

Moderate
severity level
42 units
affected scope
Class II
classification
January 13, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0577-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0577-2016) was formally reported on January 13, 2016, with the manufacturer initiating the action on November 12, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Corflex is listed as the recalling firm, operating out of Manchester, NH. Federal records list the affected scope as 42 units.

The documented reason for this recall is: 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, Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category — 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

42 units

Related Recalls

6

6 from same agency

Product description

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 high tibial osteotomies.

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,

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0577-2016
Date reported January 13, 2016
Date initiated November 12, 2015
Recalling firm Corflex
Firm location Manchester, NH
Affected scope 42 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

42 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0577-2016) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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 high tibial osteotomies.. Recalled by Corflex. Units affected: 42 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0577-2016.
Where was the recalled product distributed?
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0577-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L… →

Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 13, 2016.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.