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U.S. Department of Health and Human Services

Class 2 Device Recall Drill Bits

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 Class 2 Recall
Drill Bits
see related information
Date Posted January 13, 2009
Recall Status1 Open
Recall Number Z-0548-2009
Recall Event ID 49510
Product Classification Bit, Drill - Product Code HTW
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.
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 99
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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