Recall Z-1168-2012 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
| Date | Mar 6, 2012 (initiated Jan 27, 2012) |
| Status | Terminated |
| Reason | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
| Root cause | Process control |
| Action | DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871. |
| Quantity | 56468 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040827 | PANALOK LOOP ANCHOR Depuy Mitek, A Johnson & Johnson Company, Apr 30, 2004 |