| | Class 2 Device Recall Saw Blade |  |
| 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-0569-2009 |
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| Recall Event ID |
49510 |
| Product Classification |
blade - Product Code GFA
|
| Product | Saw Blade
Model #'s:
BIO506112
BIO506113
DEP2555-91-000
DEP5627-11-500
HAL5023-118
HAL5059-32
HAL5071-133
HAL5071-145
HAL5071-163
HAL5071-181
HAL5071-572
HOWHB-NST-6828-7-791
HOWHB-NST-6828-7-792
KOMK-2000-65
KOMKM-004
KOMKM-005
KOMKM-101
KOMKM-101C
KOMKM-102
KOMKM-234
KOMKM-275R
KOMKM-3101
KOMKM-3107
KOMKM3-225
KOMKM-325R
KOMKM-619
KOMKM-660
KOMKM-693
LIN5023-170
MICSO-601
MICSO-610
MICSP-414A
MICZO-062
MICZO-7052
MMM5756
STR2108-100
STR2108-102
STR2108-105
STR2108-107-4
STR2108-109
STR2108-110
STR2108-113
STR2108-115
STR2108-118
STR2108-120
STR2108-125
STR2108-140
STR2108-140-6
STR2108-148
STR2108-150
STR2108-150S2
STR2108-151
STR2108-152
STR2108-152-6
STR2108-158
STR2108-160
STR2108-161-2
STR2108-183
STR2108-185
STR2108-189
STR2108-192
STR2108-218
STR2108-302
STR2108-309
STR2108-351
STR2108-356
STR2296-3-103
STR2296-3-105
STR2296-3-111
STR2296-3-115
STR2296-3-125
STR2296-3-212
STR2296-3-225
STR2296-33-105
STR2296-33-111
STR2296-33-125
STR2296-3-412
STR2296-3-414
STR2296-3-511
STR277-88-100
STR277-88-125
STR277-96-250
STR277-96-275
STR277-96-277
STR277-96-325
STR277-96-326
STR298-97-100
STR4111-107-090
STR4125-089-075
STR4125-097-090
STR5100-137-233
STR5301-30-172
STR5301-40-33
STR6113-127-90
STR6125-89-75
SYN11-2217
SYN11-3500
SYN11-3534
TER98-0702-1234-9
ZIM5979-95-35 and
ZIM5979-95-41
Surgical instruments motors and accessories are AC-powered, battery-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 | 370 |
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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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