| | Class 2 Device Recall Burrs |  |
| Date Initiated by Firm | August 08, 2008 |
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| Date Posted | January 13, 2009 |
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| Recall Status1 |
Terminated 3 on April 26, 2011 |
| Recall Number | Z-0550-2009 |
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| Recall Event ID |
49510 |
| Product Classification |
Burrs - Product Code GFF
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| 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. |
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| 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 |
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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 |
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FDA Determined
Cause 2 | Packaging process control |
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| 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. |
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| Quantity in Commerce | 125 |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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