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U.S. Department of Health and Human Services

Class 2 Device Recall Burrs

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 Class 2 Recall
Burrs
see related information
Date Posted January 13, 2009
Recall Status1 Open
Recall Number Z-0550-2009
Recall Event ID 49510
Product Classification Bur, Surgical, General & Plastic Surgery - Product Code GFF
Product Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5091-112 HAL5091-122 HAL5091-125 HAL5091-136 HAL5091-144 HAL5091-164 HAL5092-120 HAL5092-168 HAL5092-170 KOM04-D0139 LIN5091-101 LIN5091-102 LIN5091-142 LIN5092-132 LIN5092-160 MED874-447 MICZB-228 MICZB-232 MID14CY50 MID14MH30D MIDG6-450 MIDG8-130 MIDMC254 STR1607-2-35 STR1608-6-137 STR1608-6-141 STR1608-6-149 STR277-10-62 STR5120-10-40 STR5120-10-50 STR5120-71-48 STR5300-10-511 STR5300-10-513 STR5300-10-903 STR5300-20-513 STR5300-30-903 XOM31-55641 ZIM5056-116 ZIM5056-117 ZIM5056-118 ZIM5056-125 ZIM5056-140 ZIM5056-150 ZIM5056-159 ZIM5056-161 ZIM5056-162 ZIM5056-164 and ZIM5056-167 Surgical instruments motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue.
Code Information n/a
Recalling Firm/
Manufacturer
Sterilmed Inc
11400 73rd Ave N Ste 100
Osseo, Minnesota 55369-5562
Manufacturer Reason
for Recall
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
Quantity in Commerce 125
Distribution AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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