Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
This recall has been terminated (originally issued March 6, 2012).
- Recall Initiated
- January 27, 2012
- Posted
- March 6, 2012
- Terminated
- August 5, 2015
- Recall Number
- Z-1171-2012
- Quantity
- 12774
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
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, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
Lot / Code Info
Lot Numbers: 3262755 3262756 3270106 3291257 3307440 3323863 3335678 3343572 3354334 3363896 3372273 3375075 3380458 3394953 3408382 3408383 3416204 3423417 3425970 3431092 3432783 3441035 3447934 3455145 3459761 3464330 3492974 3504852 3508403 3508489 3525498 3528634 3534545 3540175 3541390 3550945 3554352 3556295 3557173 3558967 3562227 3566060 3568042 3568050
Root Cause
Process control
Action Taken
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.