Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
This recall has been terminated (originally issued October 3, 2006).
- Company
- Smith & Nephew Inc
- Recall Initiated
- August 29, 2006
- Posted
- October 3, 2006
- Terminated
- April 12, 2010
- Recall Number
- Z-0009-2007
- Quantity
- 505 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Tibial punches were not manufactured to specification and could break at the tip during use.
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.
Lot / Code Info
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
Root Cause
Other
Action Taken
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.