CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report
DePuy Mitek Fully Fluted Reamer, Sterile Product Number recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile, distributed nationwide in the US. The recall was initiated on 16 Nov 2012 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-0529-2013
- FDA event ID
- 63732
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2012
- FDA classified
- 17 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 16 Nov 2012 | Recall initiated by company | |
| 17 Dec 2012 | Classified by FDA | +31 days |
| 26 Dec 2012 | 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
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Where it was distributed
Nationwide Distribution including IL and NJ
Questions about this recall
Is DePuy Mitek Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile recalled?
Yes. DePuy Mitek, Inc., a Johnson & Johnson recalled DePuy Mitek Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile on 16 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0529-2013.
Why was it recalled?
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
Which lots are affected?
Lot Number: 3611687
Where was it sold?
Nationwide Distribution including IL and NJ
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.
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| 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 |