CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
COR Disposable Kit Cartilage Transplant System recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling COR Disposable Kit Cartilage Transplant System, distributed nationwide in the US. The recall was initiated on 24 Feb 2025 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-1314-2025
- FDA event ID
- 96347
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Feb 2025
- FDA classified
- 11 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Feb 2025 | Recall initiated by company | |
| 11 Mar 2025 | Classified by FDA | +15 days |
| 19 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device is missing the pin in the graft loader component.
Product as listed by the FDA
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Where it was distributed
Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.
Questions about this recall
Why was it recalled?
Device is missing the pin in the graft loader component.
Which lots are affected?
Model No. 252109 & 252112; GTIN: 10886705012374 & 10886705012404; Lot No. 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07 & 24N10.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | COR Disposable Kit w/ Perpendicularity recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
More recalls from DePuy Mitek, Inc., a Johnson & Johnson
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | COR Disposable Kit w/ Perpendicularity recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Plus w/ OC-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
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