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U.S. Department of Health and Human Services

Class 2 Device Recall Burrs

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 Class 2 Device Recall Burrs see related information
Date Posted January 13, 2009
Recall Status1 Terminated on April 26, 2011
Recall Number Z-0550-2009
Recall Event ID 49510
Product Classification Burrs - 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 MN 55369-5562
For Additional Information Contact
763-488-3400
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
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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