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Class 2 Device Recall Journey Nonporous FinStem Tibial Punch |
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Date Initiated by Firm |
August 29, 2006 |
Date Posted |
October 03, 2006 |
Recall Status1 |
Terminated 3 on April 12, 2010 |
Recall Number |
Z-0009-2007 |
Recall Event ID |
36293 |
Product Classification |
Tibial Punch - Product Code LXH
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Product |
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
Code Information |
Catalog number 74018811 Lot Numbers: 06CM3493, 06CM03494, 06CM11279, 06CM11280, 06DM01843, 06DM01844, 06EM04235, 06EM04236, 06EM04237, 06EM07308, 06FM11461, 06FM11462, 06GM00024, 06GM00025, 06GM00026, 06GM00027, 06GM00028 Catalog number 74018813 Lot Numbers: 06CM03491, 06CM03492, 06CM03492A, 06DM09155, 06DM09156, 06DM09157, 06DM09158, 06DM12567, 06DM12568, 06DM12569, 06DM12570, 06DM12571, 06EM07309, 06EM07310, 06FM02041, 06FM02042, 06FM11464, 06FM11465, 06GM06530, 06GM06531 Catalog number 74018815 Lot Numbers 06CM03489, 06CM03490, 06CM03490A, 06CM11283, 06CM11284, 06DM01852, 06DM01853, 06DM09532, 06DM09534, 06DM09535, 06DM09536, 06FM11466, 06FM11467, 06GM00029, 06FM00030, 06GM00031, 06GM00032, 06GM06532, 06HM05954, 06HM05955, 06HM05956, 06HM05957, 06HM05958, 06HM05959 Catalog number 74018817 Lot Numbers: 06CM03486, 06CM03487, 06CM03488, 03CM03488A, 06CM12230, 06CM12231, 06DM01851, 06DM12572, 06DM12573, 06DM12574, 06DM12575, 06DM12576, 06FM11468, 06FM11469, 06GM00033, 06GM00034, 06GM00035, 06GM00036, 06GM10621 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact |
Victor Rocha 901-399-6771
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Manufacturer Reason for Recall |
Tibial punches were not manufactured to specification and could break at the tip during use.
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FDA Determined Cause 2 |
Other |
Action |
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product. |
Quantity in Commerce |
505 units |
Distribution |
Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela. |
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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