Recall Z-0317-2012 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
| Date | Nov 30, 2011 (initiated Oct 31, 2011) |
| Status | Terminated |
| Reason | Incorrect suture configuration |
| Root cause | Employee error |
| Action | The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 |
| Quantity | 585 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR Depuy Mitek, A Johnson & Johnson Company, May 2, 2007 |