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.
Reported: October 15, 2014 Initiated: September 3, 2014 #Z-0038-2015
Product Description
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.
Reason for Recall
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 875 units
- Distribution
- Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 875 units.
Why was this product recalled? ▼
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2014. Severity: Moderate. Recall number: Z-0038-2015.
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