Reported Oct 15, 2014 · Terminated
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
- Lot codes and dates
J0111J0211J0411J0611J0911J1211NB12649NB12650NB12651NB12652NB12653NB12654NB12655NB12656NB23480NB23481NB3584NB3586NB3587NB3588NB3590NB3591NB5955NB7894NB8016NB8017NB8018NB8019NB8020NB8021NB8022NB8023578910578913R578910R578912R578913582631and 592125
- Amount recalled
- 875 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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