FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Recall number
- Z-1170-2012
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Status
- Terminated
- Initiated
- 2012-01-27
- Posted
- 2012-03-06
- Terminated
- 2015-08-05
- 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
- 20476 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, 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, serial or model codes
- Lot Numbers: 3260754 3260755 3267471 3267856 3279142 3283274 3294346 3308178 3316616 3324437 3335675 3335680 3335912 3345809 3348331 3356158 3356931 3363895 3367218 3372238 3376111 3379721 3392180 3396183 3399549 3402848 3407843 3407853 3411158 3411464 3413924 3414791 3415998 3425969 3430034 3432456 3432784 3438970 3442424 3446284 3447178 3456890 3464329 3466042 3469505 3471047 3477613 3482031 3485711 3496678 3504580 3508148 3508476 3508983 3529766 3534930 3539137 3547740 3551900 3554353 3557169 3557795 3558963 3560269 3560274 3562017 3566058 3568048 3571646
- 510(k) numbers
- ["K040827"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28