| | Class 2 Device Recall Drill Bits |  |
| 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-0548-2009 |
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| Recall Event ID |
49510 |
| Product Classification |
Drill Bits - Product Code HTW
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| Product | Drill Bits
Model #'s:
DEP14043
MIC8053-019
RIC21-0438
RIC21-0439
RIC21-0441
RIC21-0442
RIC71173504
RIC71173505
RIC71631117
SMI21-0445
STR5800-4-125
STR60-13570
SYN03.010.060
SYN03.010.061
SYN03.010.101
SYN310.19
SYN310.24
SYN310.25
SYN310.288
SYN310.31
SYN310.35
SYN310.431
SYN310.44
SYN310.63
SYN310.65
SYN310.66
SYN310.67
SYN315.28
SYN315.40
SYN315.92
SYN317.861
SYN317.871
SYN356.982
SYN357.407
ZIM00-2318-020-00 and
ZIM5056-146
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
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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 | 99 |
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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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